Levocet-D

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Levocet-D

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Levocet-D

What is Levocet-D? Definition and Pharmacological Classification

Property Description
Active Ingredients Levocetirizine Dihydrochloride, Phenylephrine Hydrochloride
Form Oral Tablet
Pharmacological Class Antihistamine and Decongestant Combination
General Purpose Symptomatic relief for allergic symptoms and nasal congestion
Origin Synthetic Compounds

Levocet-D is a fixed-dose combination (FDC) pharmaceutical product classified as an Antihistamine and Decongestant combination. This systemic agent is formulated to provide combined relief from common symptoms associated with Allergic rhinitis and the common cold. The drug entity is a dual-action preparation, not a single-ingredient drug, designed to address multiple facets of upper respiratory distress. Levocet-D is typically administered as an oral tablet, representing a synthetic compound approach to managing these conditions, a method clinically recognized for systemic symptom control.


Composition: Levocetirizine and Phenylephrine Hydrochloride

The formulation contains the two distinct active ingredients: Levocetirizine Dihydrochloride and Phenylephrine Hydrochloride. Levocetirizine functions as a Peripheral H1 receptor antagonist, while Phenylephrine acts as a Sympathomimetic agent.

This specific composition is defined by the complementary roles of its components. Levocetirizine selectively blocks the effects of histamine, a key mediator of allergic symptoms. This means the medication helps lessen the body's overreaction to allergens, reducing symptoms like sneezing. Conversely, Phenylephrine is an alpha-adrenergic agonist, a mechanism essential for promoting vasoconstriction and reducing the swelling of the nasal lining. Sympathomimetics effectively reduce nasal swelling by constricting blood vessels in the mucosa.


General Purpose and Therapeutic Orientation

The overall general purpose of Levocet-D is to offer comprehensive relief by mitigating both the allergic response and nasal congestion simultaneously. This dual-action formula is oriented toward managing symptoms where mucosal swelling and fluid buildup are present alongside typical allergic manifestations.

A typical use scenario involves relief during periods of high pollen counts, where the allergic symptoms are compounded by significant nasal obstruction. The combination's ability to effect the reduction of mucosal edema through the decongestant component is crucial to its utility, helping individuals breathe more comfortably when experiencing combined allergic and obstructive symptoms.

Regulatory References

  1. MedlinePlus on Levocetirizine

What side effects are possible with Levocet-D?

Possible Side Effects and Safety Information

The safety profile of Levocet-D, a fixed-dose combination of an antihistamine (Levocetirizine) and a decongestant (Phenylephrine), reflects the officially documented adverse reactions and constraints of its components, as classified by government regulatory authorities.


Frequency-Classified Adverse Reactions

Adverse reactions are officially documented by frequency, based on clinical trials for the monotherapies. Reactions classified as Common (ge 1/100 to < 1/10) include Somnolence (drowsiness), Dry Mouth, Headache, and Fatigue/Asthenia (weakness). Uncommon (ge 1/1000 to < 1/100) reactions include abdominal pain. The most frequently documented reactions are associated with Central Nervous System depression and minor Gastrointestinal disturbances.


Systemic Safety Groups and Serious Reactions

The safety profile involves effects across multiple System-Organ Classes, including the Nervous System Disorders and Gastrointestinal Disorders.

Official regulatory documents note the potential for Serious Adverse Reactions, including Hypersensitivity Reactions such as anaphylaxis and angioneurotic edema. The Phenylephrine component is associated with potential Cardiovascular Events, including Arterial Hypertension and Myocardial Ischemia (heart-related issues) due to its sympathomimetic effects. Post-marketing surveillance has also noted rare reports of Urinary Retention and serious Psychiatric Disorders.


Population-Specific Safety Considerations

The official label includes specific safety constraints for certain populations. The use of the levocetirizine component is formally Contraindicated in individuals with End-Stage Renal Disease (creatinine clearance less than 10 mL/min). Furthermore, dose adjustment is required for older adults and pediatric patients who have impaired kidney function. The label also advises caution for individuals with predisposing factors for urinary retention (e.g., prostatic enlargement) and pre-existing cardiovascular conditions.

Overdose and Emergency Response

Overdose and when to seek help

Overdose with this combination product reflects the documented toxicities of both active components. Officially documented overdose presentations include central nervous system (CNS) effects such as drowsiness and somnolence. Sympathomimetic overactivity from the decongestant component may manifest as headache, nervousness, excitability, tremor, nausea, and vomiting.

Overdose is associated with the potential for severe and life-threatening outcomes, primarily cardiovascular. Documented serious manifestations include hypertensive crisis, severe bradycardia, decreased cardiac output, and myocardial ischemia. Immediate medical attention is required upon known or suspected overdose due to these risks. Hospital monitoring is necessary, with an emphasis on continuous cardiac observation.

Management is defined as strictly symptomatic and supportive treatment. The official labeling states that no specific antidote is known for the antihistamine component, and dialysis is documented as ineffective for its removal. Regulatory notes indicate that pediatric overdose may initially present with agitation and restlessness before drowsiness. Individuals with renal impairment are noted to have increased risk for adverse effects, compounding overdose severity.

Therapeutic Uses of Levocet-D

Levocet-D is commonly used for the symptomatic management of conditions characterized by periods of heightened symptoms related to allergies and congestion, particularly allergic rhinitis (seasonal and perennial) and upper respiratory distress associated with the common cold. This application is primarily applied across domains where additional symptomatic support is needed to address acute or disruptive symptom patterns.

The combination is commonly used for managing a cluster of symptoms that interfere with daily comfort, including distressing manifestations such as sneezing, runny nose, itchy eyes, nasal congestion, and blocked nasal passages. This application provides support that helps ease the overall symptom burden during episodic flare-ups.

“The primary symptomatic support offered involves easing the simultaneous discomfort of allergy-driven irritation and physical nasal obstruction.”

The medication assists with maintaining functional stability and contributes to improved day-to-day comfort during symptomatic periods.


Quick Fact: Relief for Nasal Congestion The formulation is relevant for easing symptoms related to swollen nasal tissues and fluid accumulation. This supportive action is relevant for easing symptoms related to swollen nasal tissues.

Regulatory References

  1. Health Canada guidance on nonprescription cough and cold product indications

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Levocet-D

This section summarizes the official population eligibility and non-eligibility information for the Levocetirizine/Phenylephrine combination, as stated in regulatory documents.

Classification Population Status Rule Description
Allowed Adults and Adolescents Permitted for individuals 12 years of age and older under standard labeled conditions.
Patients with Solely Hepatic Impairment Use is generally permitted without mandatory dosage adjustment based on liver function alone.
Contraindicated End-Stage Renal Disease Absolute prohibition for patients with Creatinine Clearance (CLcr) less than 10 mL/min or those undergoing hemodialysis.
Severe Cardiovascular Disease Contraindicated in patients with severe or uncontrolled hypertension and severe coronary artery disease.
Hypersensitivity Absolute prohibition for individuals with known allergy to the active ingredients or related compounds (e.g., cetirizine).
Restricted Use Renal Impairment (CLcr 10-80 mL/min) Use is restricted and requires a specific, individualized dose adjustment based on the severity of the kidney impairment.
Pregnancy and Lactation Use during pregnancy is permitted only if the potential benefit outweighs the potential risk. Use is not recommended while breastfeeding.
Not Recommended Children Under 12 Years The combination tablet formulation is generally not recommended for this age group, though the liquid formulation may have different rules.

Connection to the overall eligibility profile

Regulatory documents strictly define eligibility by prohibiting use in populations based on absolute contraindications, such as severe cardiovascular disease or end-stage kidney failure. They also establish conditional use for populations with certain comorbidities or organ dysfunction, such as moderate renal impairment, which mandates a restricted and individualized dosage. This framework is derived from the official product labeling to ensure usage within established safety parameters.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Levocet-D, based on government regulatory labeling and prescribing information.


Formal Contraindicated Combinations and Timing

Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is a formal contraindication as listed in regulatory documents. This restriction is due to the Phenylephrine component's pressor effects, which risk a severe hypertensive crisis when combined with MAOIs. A mandatory 14-day separation period must be observed after the discontinuation of an MAOI before this product can be administered.


Pharmacodynamic and Exposure Interactions

Interactions are generally classified by the additive effects of the active components:

  • Central Nervous System (CNS) Depressants: Co-administration with alcohol or other CNS depressants (e.g., sedatives, tranquilizers) may lead to additive CNS depression, potentiating the effects of the Levocetirizine component.
  • Cardiovascular Agents: Combining the product with other Sympathomimetic Agents or Tricyclic Antidepressants increases the risk of enhanced pressor effects and other adverse cardiovascular events. The medication may also reduce the efficacy of Antihypertensives and Beta-blockers.
  • Food: Ingestion with food results in a decrease in the maximum plasma concentration (Cmax) of Levocetirizine, although the total drug exposure (AUC) remains unchanged.

Mechanism of Action

Peripheral H1 Receptor Inverse Agonism (Levocetirizine)

Levocetirizine operates by highly selective inverse agonism at the peripheral H1 receptors, stabilizing them in an inactive conformation. This action results in the suppression of H1-mediated signaling, limiting the histamine-induced increase in capillary permeability and plasma extravasation. This modulation of the H1 pathway contributes to the pharmacological profile of the compound.

Localized alpha1 Adrenergic Vasoconstriction (Phenylephrine)

Phenylephrine acts as a direct agonist on the alpha1 adrenergic receptors primarily located on vascular smooth muscle within the nasal mucosa. This sympathomimetic action initiates a cellular cascade that causes localized vasoconstriction of engorged capillaries. This action results in the modulation of local vascular tone, producing vasoconstriction that decreases mucosal blood volume.

Complementary Mechanistic Synergy

The combination operates through two distinct mechanistic domains: Levocetirizine modifies the inflammatory mediator pathway, while Phenylephrine modulates local vascular tone. This dual-mechanism approach modulates both the chemical signaling and the vascular changes that occur in the nasal tissue.

Dosage and Administration Information

Instruction Map: How to use Levocet-D — Administration Guidelines

This section outlines the instructions for the administration of Levocet-D (Levocetirizine / Phenylephrine FDC).


Administration Scope

Instruction Detail
Route of administration The product is an oral tablet and is strictly for ingestion (by mouth).
Dosing schedule The standard adult dose (Ages 12 years and older) is one tablet. The maximum daily exposure is two tablets per 24 hours.
Timing in relation to meals (if applicable) The tablet may be taken with or without food.
Preparation requirements (if applicable) The tablet must be swallowed whole; it should not be crushed, broken, or chewed.
Age-group administration rules A dose adjustment is required for individuals aged 12 years and older who have confirmed renal impairment (reduced kidney function).
Missed-dose rules If a dose is missed, take it when remembered, unless the time for the next scheduled dose is near. Do not take two doses at the same time.
Special procedural conditions The maximum daily dose must not be exceeded to manage overall exposure to the combination's components.

Instruction Classifications (High-Level)

Classification Detail
Administration method type Oral solid (Tablet).
Frequency pattern Twice Daily (divided use).
Basis of instructions Reflects the known parameters for combination products and the Levocetirizine component.
Use-context constraints Usage is characterized by the requirement to modify the regimen in the presence of renal impairment.

Resulting Procedural Structure

Step sequence:

  • Ingest one tablet orally, regardless of food consumption status.
  • Repeat the dosage after approximately 12 hours to maintain the twice-daily schedule.
  • Ensure the tablet is swallowed whole without crushing, chewing, or breaking.
  • If a dose is missed, take it when remembered unless the next scheduled dose is imminent, and never double the dose.

Connection to the overall use protocol: The standard protocol involves a twice-daily, oral administration with an explicit maximum dose limit. This protocol standardizes the use of the combination and is modified for patients with reduced kidney function.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Levocet-D


Evidence for Use in Seasonal Allergies

Research explored how Levocet-D was associated with changes in patient-reported outcomes describing discomfort and outcomes reflecting daily functioning in patients with seasonal allergic rhinitis. Studies examined how frequently and severely symptoms like sneezing and itchy eyes were experienced during periods of high pollen exposure. Findings describe patterns observed in the studies where participants reported changes in these short-term symptom patterns, measured over defined time intervals. However, data are still emerging regarding all aspects of this use. Follow-up durations were limited in many trials, meaning the long-term effects are not fully established, and evidence quality varies across studies.


Evidence for Use in Perennial Allergies

Levocet-D was evaluated in settings that include conditions where symptoms may vary in intensity over many months for perennial allergic rhinitis. Studies explored how symptoms changed during the defined study period, focusing on outcomes reflecting daily functioning and persistent symptoms. Data show patterns related to outcomes describing episodic changes that occur year-round. The sample sizes were modest in some studies, meaning the results apply only to the populations studied. There is limited information for long-term outcomes regarding the durability of any measured changes over many years.


Long-Term Studies and Follow-Up

Currently, long-term effects are not fully established because most trials are designed to assess short-term symptom patterns. Studies monitored participants primarily over short-to-medium timeframes. The available long-term evidence is limited and mainly consists of extension studies or observational settings, which help show what has been observed so far regarding how symptoms evolved when use is extended. Follow-up durations were limited, and the knowledge of sustained changes over several years is still uncertain.


Evidence in Special Populations and Uncertainties

Research has evaluated what was observed with Levocet-D in distinct patient groups, such as children and older adults. For older adults and those with comorbid conditions, the research is limited, and data for certain groups remain insufficient. Subgroup findings are uncertain, and the extent to which study results apply to these specific groups is an area where certainty remains low.

In summary, comparative evidence is lacking to firmly conclude relative differences against other treatments. Evidence quality varies across studies, and some conclusions are drawn from studies where the sample sizes were modest. Research does not determine whether an individual will respond similarly to the group findings, and complete understanding of Levocet-D remains an area where research is ongoing.

Key Studies & References A combination of cetirizine and pseudoephedrine has therapeutic benefits when compared to single drug treatment in allergic rhinitis

Frequently Asked Questions (FAQ)

Common questions about Levocet-D (FAQ)


Q: Is Levocet-D the same as over-the-counter cold medicine?

A: Levocet-D is a combination of two active ingredients: an antihistamine (Levocetirizine) and a decongestant (Phenylephrine). While both types of ingredients are commonly found in over-the-counter (OTC) cold and allergy medicines, this product is a fixed-dose combination. The general purpose is to combine the effects of both components for comprehensive relief.


Q: What is the difference between Levocet-D and just Levocetirizine?

A: Levocet-D is a combination product that contains both Levocetirizine and Phenylephrine. Levocetirizine is an antihistamine that helps relieve typical allergy symptoms like sneezing and itching. The addition of Phenylephrine, which is a decongestant, is intended to specifically help with nasal congestion and swelling.


Q: What happens if I miss a scheduled time for Levocet-D?

A: Official administration guidelines state that if a dose is missed, it should be taken when remembered, unless it is already near the time for the next scheduled dose. Regulatory instructions advise against taking two doses at the same time to make up for the missed one.


Q: What official warnings are associated with the decongestant part of Levocet-D?

A: The decongestant component, Phenylephrine, is associated with specific warnings in regulatory documents. These include the potential for increased blood pressure (hypertension) and other cardiovascular effects. The product is described as contraindicated for use by patients with severe heart disease or uncontrolled high blood pressure.


Q: Are there any long-term health concerns associated with using Levocet-D?

A: Regulatory-backed research summaries indicate that most clinical trials for this combination were designed to assess only short-term symptom patterns. Because of this, official research summaries indicate that evidence regarding sustained changes over many years is limited.


Q: What are the official restrictions on how long someone can use Levocet-D?

A: While specific treatment durations are not universally defined for all combination products, general regulatory guidance often describes decongestants as being for short-term use. The product is generally used on a twice-daily basis, and patients are always cautioned to not exceed the maximum daily dose specified in the official instructions.


Q: Is Levocet-D only for seasonal allergies?

A: No. Official documents describe the appropriate use of the combination for symptoms associated with both seasonal allergic rhinitis (e.g., hay fever) and perennial allergic rhinitis (year-round allergies). It is also used in other conditions where relief from both components is needed.


Q: What are the official recommendations if a person uses more Levocet-D than described?

A: Regulatory information on overdose symptoms for the components includes effects such as severe drowsiness, dizziness, and central nervous system effects. The official advice for an assumed overdose is to seek emergency medical attention immediately.


Q: Why are people with glaucoma sometimes advised against using Levocet-D?

A: The regulatory label advises caution for individuals with predisposing factors for urinary retention, such as an enlarged prostate, and for those with narrow-angle glaucoma. This is related to the actions of the combination's decongestant and antihistamine components on the body.


Q: How quickly can I expect Levocet-D to start working?

A: Clinical data for the antihistamine component, Levocetirizine, indicates that the peak concentration in the blood is typically reached in less than one hour after the tablet is taken. This information is often interpreted as suggesting a relatively quick onset of action for the antihistamine effect.


Q: How long does the effect of Levocet-D typically last?

A: The plasma half-life of the Levocetirizine component is approximately 7 to 9 hours. The product is generally administered on a twice-daily schedule to maintain symptom relief.


Q: What are the most common side effects listed for Levocet-D?

A: The most common adverse reactions listed in regulatory documents include somnolence (drowsiness), dry mouth, headache, and fatigue or asthenia (weakness). These are the effects most frequently documented in clinical trials.


Q: Can Levocet-D cause feelings of drowsiness or sleepiness?

A: Yes. The drug's antihistamine component can cause Central Nervous System depression. Somnolence (drowsiness) is officially listed as a common adverse reaction for the product, and official warnings describe caution when performing tasks that require full alertness.


Q: Is it possible to become dependent on Levocet-D?

A: No. Regulatory sources state the product is not classified as a controlled substance under the U.S. Drug Enforcement Administration (DEA) or similar international bodies. The product is not generally associated with drug abuse or dependence.


Q: Why does Levocet-D sometimes cause dry mouth?

A: Dry mouth is a known side effect listed in official documents, classified as a common reaction. This effect is often associated with the way the antihistamine and decongestant components influence certain body functions, which can lead to a reduction in saliva production.


Q: Has Levocet-D been studied in children?

A: The combination tablet formulation is generally not recommended for children under 12 years of age. Regulatory documents confirm that clinical studies and labeled dosage recommendations typically focus on individuals aged 12 years and older.


Q: What do official documents say about using Levocet-D during pregnancy?

A: Official prescribing information states that use during pregnancy is restricted and is generally permitted only if the potential benefit outweighs the potential risk to the fetus. The decision to use it while pregnant is to be determined by a healthcare professional.


Q: Is Levocet-D safe to use while breastfeeding?

A: Official documents state that the product is not recommended while breastfeeding. This is due to the potential for the components of the drug to be excreted in breast milk and cause adverse effects in a nursing infant.


Q: Can Levocet-D affect my ability to drive or operate machinery?

A: Yes. Due to the risk of common side effects such as drowsiness, dizziness, or somnolence, official warnings describe caution when performing activities that require full mental alertness, such as driving a car or operating machinery.


Q: Does Levocet-D interact with caffeine?

A: Regulatory warnings advise caution when combining this product with other stimulants. The Phenylephrine component is a sympathomimetic, and combining it with stimulants like caffeine can potentially lead to enhanced cardiovascular and central nervous system effects.


Q: Is it normal to feel a bit restless after taking Levocet-D?

A: Official documents note that rare or post-marketing reports have included effects such as agitation or restlessness. These effects are generally associated with the decongestant component of the product, which can sometimes have stimulating effects.


Q: Can Levocet-D cause changes in mood or anxiety?

A: Official documentation has noted rare reports of serious Psychiatric Disorders associated with the product components. These events, which may include changes in mood or anxiety, are monitored through post-marketing surveillance by regulatory bodies.


Q: How does the action of Levocet-D differ from older allergy and cold medicines?

A: The antihistamine component is classified in regulatory sources as a second-generation antihistamine. These newer antihistamines are generally defined by a different profile compared to older, first-generation antihistamines, specifically regarding a reduced potential for sedation.


Q: Is Levocet-D approved by the FDA or similar international bodies?

A: Yes. The combination product, or its equivalent active components, has undergone review and is approved by authoritative bodies like the U.S. Food and Drug Administration (FDA) and other international regulatory agencies for its labeled indications.


Q: Does Levocet-D affect sleep patterns?

A: Yes. The most common impact on sleep is somnolence (drowsiness) due to the antihistamine. However, the decongestant component is a stimulant, and rare reports of insomnia or restlessness may also be reported, as noted in official information.


Q: Are there specific tests someone needs before starting Levocet-D?

A: The regulatory label requires a dose adjustment based on kidney function for individuals with renal impairment. This suggests that some assessment of kidney function may be necessary, particularly for at-risk individuals, before the medication is started.


Q: What does the research say about the effectiveness of Levocet-D compared to placebo?

A: Research summaries state that studies examined how the drug was associated with changes in symptoms and daily functioning in patients. The evidence is described as demonstrating patterns of effect on short-term symptoms over defined time intervals when compared to control groups.


Q: Can Levocet-D be used for chronic conditions?

A: Yes. The active ingredients are indicated for symptoms of conditions that can be chronic, such as perennial allergic rhinitis (year-round allergies). Official information is primarily focused on controlling symptoms within the established safety profile.


Q: Is Levocet-D described as a non-sedating drug?

A: The antihistamine component is classified as a second-generation antihistamine, which is generally considered less sedating than older types. However, somnolence (drowsiness) is officially listed as a common side effect.


Q: Does Levocet-D have any known effects on kidney function?

A: Yes. Regulatory documents confirm a known relationship with kidney function, stating that the drug is contraindicated in patients with end-stage kidney disease. A dose adjustment is also required for individuals with moderate to severe renal impairment.


Q: What is the main concern about taking Levocet-D near bedtime?

A: The main concern about taking it near bedtime is the risk of somnolence (drowsiness), as this is a common side effect of the antihistamine component. Taking it at night is often discussed as a way to manage the potential for daytime drowsiness.


Q: Does Levocet-D help with sinus pressure?

A: The Phenylephrine component is a decongestant specifically intended to relieve symptoms of nasal congestion and swelling. Congestion is often a major contributor to feelings of sinus pressure, and the decongestant is intended to address this swelling.


Q: Are there different strengths of Levocet-D available?

A: Regulatory documents list the specific strengths of the active ingredients (Levocetirizine and Phenylephrine) in the combination tablet. The tablet typically comes in one standard dose combination, although other formulations, such as liquids, may exist for different populations.


Q: Is there a risk of rebound congestion with Levocet-D?

A: The risk of rebound congestion is a well-known warning associated with nasal spray decongestants, which are used topically. Because Levocet-D is an oral product, this specific warning regarding the worsening of congestion upon stopping the drug may not apply in the same way as with topical decongestants.


Q: Does Levocet-D contain any substances that are monitored or controlled?

A: No. Official regulatory schedules confirm that the active ingredients are not classified as controlled substances under U.S. or equivalent international acts. Therefore, the product is not subject to special monitoring or prescribing rules for controlled medications.


Q: Can I take other cold medicines with Levocet-D?

A: Regulatory warnings state that taking this product with other sympathomimetic agents (like other decongestants) or other antihistamines is noted in regulatory warnings as potentially increasing the risk of side effects. This includes a potential for additive effects like enhanced cardiovascular effects or increased drowsiness.


Q: Can Levocet-D make existing anxiety worse?

A: Official information includes rare reports of agitation, restlessness, and psychiatric disorders, which are side effects that could potentially impact existing anxiety. These events are monitored by regulatory bodies in post-marketing surveillance.

How should Levocet-D be stored and disposed of?

How to Store and Dispose of Levocet-D?

Storage and disposal must strictly adhere to the conditions documented in regulatory labeling to maintain product stability and ensure safety.


Official Storage Conditions

Levocet-D tablets must be stored at controlled room temperature, specifically between 20°C and 25°C (68°F and 77°F). It is mandatory to keep the medicine in its original container, tightly closed, and protect it from excess heat and moisture. The product should not be frozen.

Child Safety and Disposal

All medicines, including Levocet-D, must be stored out of the sight and reach of children.

For disposal of unused or expired tablets, the official guidance is to use a community drug take-back program. If this option is not available, the product should be prepared for household trash disposal by mixing it with an unappealing substance; do not flush the medicine down the toilet.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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