Lorinase

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Lorinase

Method of action: Antitussive, Nasal Preparations

Treatment option:

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 Lorinase

Quick Facts

Property Description
Active Ingredients Loratadine, Pseudoephedrine sulfate
Form Oral Tablet (including extended-release), Syrup/Oral Solution
Pharmacological Class Antihistamine and Decongestant Combination
Common Use Relief of symptoms associated with allergies and congestion
Origin Synthetic

Lorinase is a fixed-dose combination medication classified as an Upper Respiratory Combination drug, designed for the systemic relief of symptoms related to allergies and the common cold. The medication is a generic term for the blend of two distinct, synthetic active compounds: the antihistamine Loratadine and the sympathomimetic decongestant Pseudoephedrine sulfate. The high-level purpose of Lorinase is to simultaneously treat both the allergic reaction and the physical obstruction of nasal passages.


What Type of Medicine is Lorinase? (Definition and Classification)

Lorinase is fundamentally a combination product that integrates two complementary therapeutic agents into a single unit for oral administration. The medication is pharmacologically categorized as a blend of a second-generation antihistamine and a nasal decongestant. Specifically, Loratadine belongs to the class of selective H1-receptor antagonists, which means it helps block a key chemical responsible for allergic reactions. Pseudoephedrine is an alpha-Adrenergic Agonist, recognized for its action in reducing the swelling of nasal tissue. This dual classification is clinically supported, demonstrating that the combination is more effective than treating allergic rhinitis with either ingredient alone.

The Active Ingredients and Form (Composition and Identity)

The core composition utilizes the International Nonproprietary Names (INN) Loratadine and Pseudoephedrine sulfate. Both are synthetic agents, though Pseudoephedrine is structurally derived from a compound naturally occurring in the Ephedra plant. Lorinase is typically supplied in oral dosage forms, including standard and extended-release Tablets as well as a liquid Syrup/Oral Solution. The benefit of the common extended-release tablet is the sustained systemic action, which is clinically recognized for providing long-lasting relief from symptoms like nasal stuffiness.

General Purpose and Benefit (High-Level Use)

The general purpose of this combination medicine is to achieve comprehensive symptom relief by managing two key pathological components concurrently. The Loratadine component works by blocking the action of histamine to relieve symptoms such as sneezing and itching. Blocking this chemical helps reduce the irritating effects of the allergy. The Pseudoephedrine component, in turn, causes vasoconstriction in the nasal lining, which aids in helping to clear nasal and sinus congestion. This dual approach provides a systemic benefit that manages both the underlying allergic trigger and the resulting physical blockage, which is useful when allergy symptoms, such as those caused by seasonal pollen, are accompanied by significant nasal congestion.

Regulatory References

  1. DailyMed
  2. National Institutes of Health
  3. NIH

What side effects are possible with Lorinase?

Possible Side Effects and Safety Information

The safety profile of Lorinase, a combination of Loratadine and Pseudoephedrine sulfate, is officially documented through established regulatory classifications, primarily encompassing adverse reactions across key physiological systems.

Adverse Reaction Classification

Official labeling defines side effects by frequency. Commonly documented adverse reactions include Nervousness, Dry mouth, Insomnia (trouble sleeping), Headache, and Dizziness. These are reported frequently in the data supporting regulatory approval.

Adverse reactions are formally grouped into System-Organ Classes (SOCs). Effects on the Nervous System include Sleeplessness, Tremor, and, rarely, Convulsions. Due to the sympathomimetic component, effects on Cardiac and Vascular Disorders include Palpitations, Tachycardia (rapid heartbeat), and Hypertension (high blood pressure).

Gastrointestinal Disorders such as Dry mouth, Nausea, and Gastritis are also documented.

Classification Examples of Officially Documented Effects
Common Insomnia, Dry mouth, Nervousness, Headache, Dizziness
Serious/Rare Angioedema, Anaphylaxis, Convulsions, Severe Tachycardia

Safety Considerations for Specific Populations

Official regulatory documents contain specific safety notes for certain patient groups. Older Adults may show increased sensitivity to side effects, especially CNS effects (e.g., confusion) and cardiovascular effects. Use in patients with Severe Renal or Hepatic Impairment requires caution, often requiring dose modification to manage the risk of increased drug exposure. The safety and efficacy for use in children under 12 years are not established, as noted in the official prescribing information.

Serious Adverse Reactions officially listed include severe Hypersensitivity Reactions (such as Angioedema or Anaphylaxis) and certain severe Cardiac Events.

Overdose and Emergency Response

Overdose and When to Seek Help

A Lorinase overdose may present with a dual set of symptoms reflecting the effects of both active ingredients, requiring immediate medical attention. Documented manifestations include signs of central nervous system (CNS) depression, such as severe drowsiness and somnolence from the antihistamine component, and signs of CNS stimulation, such as tachycardia, tremors, or insomnia, from the decongestant component.

The official regulatory documents classify overdose as a risk for life-threatening systemic outcomes. These include convulsions, cardiac arrhythmias, and cardiovascular collapse with accompanying hypotension. Furthermore, urgent medical assistance must be sought if symptoms suggestive of Posterior Reversible Encephalopathy Syndrome (PRES) or Reversible Cerebral Vasoconstriction Syndrome (RCVS) are suspected, typically manifesting as a severe headache with a sudden onset, confusion, or seizures.

Official guidance mandates that individuals seek emergency medical attention or call the Poison Help line immediately after a suspected overdosage. This is required even if no symptoms are apparent, due to the potential for severe, delayed systemic effects. Regulatory labeling notes that CNS stimulation with convulsions or cardiovascular collapse is more likely to occur in children and the elderly. Treatment is symptomatic and supportive, and cardiac monitoring should be instituted, as no specific antidote for the combination is explicitly documented.

Therapeutic Uses of Lorinase

What Lorinase treats: main uses and benefits

Lorinase is commonly used to help manage symptoms related to inflammatory or irritative states associated with an allergic response, such as those seen in Seasonal Allergic Rhinitis (Hay Fever) and Perennial Rhinitis. This therapeutic domain covers classic allergic manifestations including frequent sneezing, a runny nose (rhinorrhea), and irritating itching of the nose, throat, or eyes. The supportive therapeutic benefit contributes to easing the overall symptom load, which may help patients cope more steadily with symptom fluctuations when they become difficult to tolerate.

The combination is applied in clinical contexts where significant nasal and sinus congestion is present, often alongside allergic symptoms or as part of a Common Cold presentation. The primary indications involve the symptomatic relief of upper respiratory issues including nasal congestion, sinus pressure, sneezing, and ocular/nasal itching. This dual approach provides assistance that may assist with the symptoms that interfere with daily functioning, such as the feeling of nasal obstruction, and assists with maintaining functional stability during phases where congestion creates noticeable interference with daily functional comfort.

Quick Fact: Dual Symptom Relief
Commonly used to manage Nasal Congestion, Sinus Pressure, Sneezing, and Itching.
Key Patient Benefit Supports maintenance of functional stability during symptomatic episodes.
Typical Context Conditions characterized by periods of heightened allergy symptoms and nasal blockage.

Regulatory References

  1. NIH DailyMed Drug Label

Eligibility and Restrictions for Use

Who Can and Cannot Use Lorinase?

Population eligibility for Lorinase (Loratadine/Pseudoephedrine) is strictly defined by regulatory documents, distinguishing between absolute contraindications and conditional use restrictions.

Contraindicated Populations

Use is contraindicated and explicitly prohibited in individuals with established hypersensitivity to the active ingredients or formulation components. Absolute non-eligibility is also defined for patients with severe hypertension or severe coronary artery disease (CAD). Furthermore, the medicine must not be used concurrently with, or within 14 days of stopping, Monoamine Oxidase Inhibitors (MAOIs).

Age and Condition-Based Restrictions

Population Group Regulatory Status Constraint Detail
Pediatrics Not Recommended Safety and efficacy are not established for children younger than 12 years of age.
Organ Impairment Not Recommended Patients with severe hepatic (liver) or severe renal (kidney) impairment fall into a non-recommended category.
Pregnancy/Lactation Not Recommended Use is generally not established during pregnancy, and the medicine is not recommended for nursing mothers.
Geriatric Patients Use with Caution Individuals 60 years and older may require careful consideration due to increased risk of certain effects.

What should I know about interactions with other medicines?

Interaction Map: Interactions with other medicines and products — official regulatory information for Lorinase

Interaction scope

Medicinal product categories with documented interactions:

  • Monoamine Oxidase (MAO) Inhibitors (including reversible and irreversible)
  • Ergot Alkaloids (Ergot Derivatives)
  • Strong CYP Enzyme Inhibitors (e.g., Ketoconazole, Erythromycin, Cimetidine)
  • Other Sympathomimetic Agents

Mechanistic basis of interactions (only if stated in label):

  • Pharmacodynamic (PD) Synergism: Leads to severe blood pressure and heart rate elevation.
  • Pharmacokinetic (PK) Inhibition: Inhibition of CYP3A4 and CYP2D6 metabolism, resulting in increased plasma concentrations of loratadine.

Timing-based interaction rules (if applicable):

  • The product is contraindicated for use in patients receiving MAO inhibitor therapy or within fourteen (14) days of discontinuing such treatment.

Population-specific interaction notes (if applicable):

  • Use of the combination product is not recommended in patients with severely impaired hepatic function due to documented effects on drug clearance.

Interaction classifications (high-level)

Interaction severity classification (as defined in official documents):

  • Contraindicated Combinations (MAO Inhibitors, Ergot Alkaloids)
  • Clinically Significant PK Alteration (CYP Inhibitors)

Interaction-context constraints (as defined in official documents):

  • A high-fat meal results in an officially documented increase in the absorption (AUC and Cmax) of the loratadine component.

Resulting interaction structure

Official interaction statements:

  • • Co-administration with MAO Inhibitors is prohibited due to the risk of hypertensive crisis, necessitating a 14-day separation period.
  • • Strong CYP Inhibitors like Ketoconazole and Erythromycin substantially increase the blood exposure of loratadine through documented metabolic inhibition.
  • • The pseudoephedrine component may cause increased ectopic pacemaker activity when used with digitalis preparations.

Connection to the overall interaction profile (2–4 sentences): The regulatory interaction profile is anchored by severe pharmacodynamic synergism, primarily demanding contraindicated status and a precise timing restriction for MAO Inhibitors. The structure also documents significant pharmacokinetic inhibition by specific drug classes that officially result in altered plasma exposure for the loratadine component.

Mechanism of Action

The combined physiological effect involves the simultaneous action of two distinct mechanistic domains: Histamine Pathway Modulation and Adrenergic Vascular Control.


Peripheral Histamine Receptor Antagonism

The Loratadine component is a selective H1 receptor antagonist (or inverse agonist) with high affinity for peripheral histamine receptors. By binding to these receptors in tissues like the nasal mucosa, it interrupts the signaling cascade initiated by histamine, a key inflammatory mediator. This mechanism leads to the stabilization of the microvascular endothelium and the reduction of excessive mediator activity. This physiological action results in decreased fluid leakage from capillaries and reduced stimulation of sensory nerves.


Adrenergic Alpha-1 Receptor Agonism

The Pseudoephedrine component is a sympathomimetic amine that acts as a mixed adrenergic alpha1 receptor agonist, both directly and by stimulating the release of norepinephrine. This mechanism targets receptors on the smooth muscle of arterioles in the nasal lining, initiating a sequence that causes the muscle to contract (vasoconstriction). This engagement modifies the early molecular steps that shape systemic physiological outcomes by supporting the regulation of processes driven by distinct signaling patterns in the sympathetic nervous system. The result is a physical reduction of blood volume in the nasal tissues.


Dual Pathway Interruption

The core physiological effect stems from the fact that the two mechanisms are complementary. Loratadine acts to suppress the chemical signals (histamine) that escalate vascular permeability and glandular secretion, while Pseudoephedrine initiates a physical, vasoconstrictive effect on the microcirculation. The combined action results in simultaneous physiological changes stemming from pathway modulation in both the inflammatory and sympathetic nervous systems.

Dosage and Administration Information

Lorinase is administered exclusively through the oral route. Use of the medicine is governed by a fixed-time schedule according to the specific formulation. The standard dose for adults and adolescents 12 years and older is one dose unit of the prescribed strength. The extended-release (ER) tablet containing 10 mg Loratadine and 240 mg Pseudoephedrine is typically administered once daily (every 24 hours). The alternative 12-hour ER tablet or oral solution is administered twice daily, every 12 hours. Regardless of the strength, the maximum dose is strictly limited to prevent overexposure to the active ingredients.

For proper administration, the extended-release tablets must be swallowed whole with water and must not be divided, crushed, chewed, or dissolved, as altering the tablet compromises its time-release mechanism. The medicine may be taken with or without food.

Treatment with Lorinase is designated for short-term use, with the general recommendation against administration beyond approximately 10 days. Specific dose adjustments are required for certain populations. Patients with severe renal or hepatic impairment are typically instructed to use a lower initial daily dose than the standard regimen. To ensure accurate results during diagnosis, the medicine must be discontinued at least 48 hours before any scheduled skin testing for allergies.

Recent Clinical Evidence

Research evidence / Overview of studies for Lorinase

Overview of Core Clinical Trials

The scientific understanding of the Lorinase (Loratadine and Pseudoephedrine) combination was evaluated in multiple regulatory-grade studies. Research has primarily centered on short- to intermediate-term Randomized Controlled Trials (RCTs). These trial designs are applied in studies examining patient-reported experiences and are used to provide the most context regarding acute symptom episodes during periods of increased symptom activity. This evidence contributes to the broader evidence landscape that regulatory bodies monitor for conditions characterized by fluctuating manifestations.

Evidence for Allergic Rhinitis (Seasonal and Perennial)

Research has explored this combination for conditions involving periods of heightened symptoms, specifically Seasonal Allergic Rhinitis (hay fever) and Perennial Allergic Rhinitis (year-round allergies). Studies were conducted exploring short-term symptom changes associated with acute or disruptive episodes.

Researchers examined patient-reported outcomes describing perceived discomfort. The outcomes studied were related to physical discomfort and linked to inflammatory or irritative states, focusing mainly on measured changes in Total Symptom Scores (TSS). Research also examined outcomes reflecting daily functioning, such as changes in Health-Related Quality of Life (QoL). Findings describe patterns observed in studies regarding how symptoms evolved in the observed populations.

Comparisons in Clinical Studies

The combination product was evaluated in studies comparing it to both a placebo (an inactive dummy pill) and to its individual active components given alone. These comparison studies were applied in research contexts involving fluctuating or unstable symptoms. Research highlights changes measured during the study period when the combination product was studied against the single components. Findings describe patterns observed in these studies regarding how symptoms evolved in the observed populations.

Evidence in Specialized Populations

The research mainly includes Adults and Adolescents (age 12 and older). Research was conducted in patients who were experiencing increased symptom activity, such as in one scenario involving patients with allergic rhinitis who also had concomitant mild asthma. Research explored patient outcomes related to both rhinitis symptoms and physiological measures, such as lung function, across the study period. Research provides context regarding outcomes in this specific group.

Follow-up Duration and Long-Term Data

Research exploring short-term symptom changes generally involved follow-up durations that were limited, primarily consisting of short-term (14 days) to intermediate-term (4 to 6 weeks) observation periods. The findings describe patterns observed in the studies only within these defined time intervals. Consequently, the research provides limited insight into long-term outcomes, and long-term effects are not fully established.

What Research Gaps Remain Documented

Despite the available evidence, data for certain groups remain insufficient, and research describes key limitations in the existing studies:

  • Long-Term Outcomes: There is limited information for long-term outcomes, and the evidence base does not provide context regarding symptom patterns over many months or years of use.
  • Children Under 12: Data for certain groups remain insufficient, as the scope of research and study patterns have not been established in children younger than 12 years.
  • Objective Measures: Research highlights that while perceived discomfort was frequently reported in patient surveys, certain objective measures (instrument-based assessments) sometimes showed less consistent patterns across studies.

Key Studies & References

  1. Loratadine and pseudoephedrine (oral route) - NIH Books/Authoritative Drug Monograph
  2. Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis

Frequently Asked Questions (FAQ)

Common questions about Lorinase (FAQ)

Q: How long do the effects of Lorinase typically last?

A: The duration of the effect for Lorinase is directly related to the specific type of tablet prescribed. According to the official product information, there are formulations designed to provide relief for either 12 hours or 24 hours to accommodate different patient needs.

Q: Does Lorinase interact with common pain relievers like ibuprofen?

A: Official information does not list non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, as a contraindicated or clinically significant drug interaction with Lorinase. The regulatory interaction profile focuses on specific classes of medicines like MAO inhibitors and certain CYP enzyme inhibitors.

Q: Are there certain foods or drinks that should be avoided while taking Lorinase?

A: Official documents advise limiting caffeine intake (found in many stimulant drinks or foods) due to the risk of additive side effects like nervousness. Additionally, it is noted that a high-fat meal may increase the absorption of the loratadine component.

Q: Is Lorinase safe to use if I have high blood pressure?

A: Use of Lorinase is contraindicated (prohibited) in individuals with severe or uncontrolled hypertension (high blood pressure) due to the decongestant component. Official safety notes indicate that caution may be appropriate for patients with high blood pressure conditions.

Q: Can Lorinase be used for children of all ages?

A: The official documentation states that the safety and efficacy of Lorinase are not established for children younger than 12 years of age. Due to the lack of evidence in this age group, use is not recommended for this population.

Q: Is Lorinase considered safe for use by the elderly?

A: Official safety documents indicate that individuals 60 years and older may be advised to use Lorinase with caution. Official safety notes indicate that this age group may show increased sensitivity to certain effects, particularly those affecting the cardiovascular system and the central nervous system.

Q: Does Lorinase have an official warning about taking it before driving?

A: Official safety information advises patients not to drive or operate machinery until they know how the medicine affects them, as it may affect coordination, reaction time, or judgment.

Q: What are the main conditions that would make someone ineligible to use Lorinase?

A: Official documents list absolute contraindications (conditions where use is prohibited), including hypersensitivity to the ingredients, severe hypertension, severe coronary artery disease, and concurrent use with MAO inhibitors. The medicine is also not recommended for patients with severe hepatic (liver) or severe renal (kidney) impairment.

Q: What does official guidance say about using Lorinase with alcohol?

A: Official guidance advises that drinking alcohol with Lorinase can increase the risk of certain side effects, such as dizziness. This potential interaction is noted in official guidance.

Q: What precautions are listed regarding Lorinase use during pregnancy?

A: The use of Lorinase during pregnancy and breastfeeding is generally not established in regulatory documents. Official labeling advises consulting a health professional before use if pregnant or breastfeeding.

Q: Can I take Lorinase for just a runny nose, or only for allergy symptoms?

A: Official labeling states that Lorinase is indicated to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. This means the medicine is described for use across a range of congestion-related symptoms.

Q: Is Lorinase known to cause drowsiness or make you sleepy?

A: While the loratadine component is often described as non-drowsy, official information indicates that drowsiness (somnolence) is a possible side effect reported in clinical trials for the combination product.

Q: Is it normal to feel a dry mouth while using Lorinase?

A: Dry mouth is listed in official documents as one of the commonly documented adverse reactions for Lorinase. This side effect was reported by a notable percentage of patients in clinical trials.

Q: If I miss a dose of Lorinase, what do I need to know?

A: Patient information indicates that if a dose is missed, the dose is generally taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose is typically skipped. A double dose must not be taken.

Q: Are there any known interactions between Lorinase and herbal supplements?

A: Official regulatory documents do not specifically list interactions with most broad categories of herbal supplements. However, caution is advised for supplements containing ingredients, such as caffeine, which could potentially worsen common side effects like nervousness.

Q: Why do people sometimes say Lorinase makes them feel jittery?

A: Official labeling lists nervousness, restlessness, and excitability as common side effects. These effects are associated with the pseudoephedrine component of the medication, which acts as a stimulant.

Q: Is Lorinase safe for people with a history of thyroid issues?

A: Official warnings state that the decongestant component may be avoided or administered cautiously in patients with hyperthyroidism (overactive thyroid) due to the potential risk of cardiovascular side effects.

Q: Is Lorinase known to cause any issues with heart rate or palpitations?

A: Official safety documents list palpitations, tachycardia (a rapid heartbeat), and hypertension (high blood pressure) as possible adverse reactions related to the sympathomimetic component of the medicine.

Q: Why is Lorinase sometimes kept behind the pharmacy counter?

A: The pseudoephedrine component is subject to specific regulatory controls in some regions due to its potential for use in the illicit manufacturing of restricted substances. These controls often require the product to be kept behind the pharmacy counter.

Q: Does Lorinase have any official use restrictions for athletes?

A: The pseudoephedrine component is classified by major anti-doping authorities as a prohibited substance during competition above a specified urinary concentration threshold. For specific use, athletes are typically directed to refer to the relevant sports regulatory body for official guidance.

Q: What does official guidance state about mixing Lorinase with stimulant drinks?

A: Official documents note that limiting caffeine intake (often found in stimulant drinks) is advised due to the risk of additive side effects like nervousness from the decongestant component. This is due to the potential for overstimulation.

Q: Does Lorinase cause stomach upset or nausea in most users?

A: Nausea is a reported side effect of Lorinase listed in the official documents. Clinical trial data for the 24-hour tablet reported nausea in 3% of patients, indicating it is not one of the most frequently experienced side effects.

Q: Is it true that Lorinase might cause anxiety in some users?

A: Official documents and postmarketing data list anxiety as a possible adverse reaction for the combination product. This is related to the stimulating effects of the pseudoephedrine component.

Q: What kind of research evidence supports the use of Lorinase for sinus pressure?

A: Research evidence for the decongestant component, pseudoephedrine, describes its mechanism as causing vasoconstriction to reduce nasal swelling and facilitate sinus drainage. This mechanism relates to the relief of pressure associated with congestion.

Q: Are there official studies comparing how Lorinase works in different age groups?

A: Clinical research has focused primarily on adults and adolescents 12 years and older. Safety notes indicate older adults (60+) may show increased sensitivity, but summaries of dedicated comparative studies between various adult age groups are not frequently detailed in the official overviews.

Q: Does taking Lorinase interact with birth control pills?

A: Official documents containing interaction information do not list hormonal contraceptives (birth control pills) as a contraindicated or clinically significant drug interaction with Lorinase.

Q: Is Lorinase generally described as a short-term or long-term allergy solution?

A: Treatment with Lorinase is designated for short-term use, according to regulatory documentation. The official product information advises against administration beyond approximately 10 days.

Q: Does Lorinase cause weight gain or appetite changes?

A: Weight gain and changes in appetite, including both increased appetite and anorexia (loss of appetite), are listed as possible adverse reactions in official documents for the medication.

Q: What level of evidence exists for Lorinase helping with eye symptoms?

A: Clinical studies have evaluated the effectiveness of Lorinase in relieving eye symptoms, including itchy eye and tearing, as part of the overall treatment of allergic rhinitis symptoms.

Q: Are there restrictions on Lorinase use for people with kidney problems?

A: The use of Lorinase in patients with severe renal impairment (significant kidney problems) is not recommended or requires a lower initial dose due to the altered clearance of the ingredients. Official documentation notes that caution is appropriate for this population.

Q: What warnings exist for Lorinase use in people with glaucoma?

A: Glaucoma is listed as a condition that requires caution. The pseudoephedrine component may occasionally increase intraocular pressure in patients with or predisposed to narrow-angle glaucoma.

How should Lorinase be stored and disposed of?

How to Store and Dispose of Lorinase (Loratadine/Pseudoephedrine)

Lorinase tablets must be stored at controlled room temperature, specifically between 20 C to 25 C (68 F to 77 F). The medication must be kept in a dry place and protected from light. It is mandatory to store the tablets in the original container, kept tightly closed, and explicitly keep from freezing.

Child Safety

The medication must always be stored out of the reach and sight of children, in a secure location, as mandated by regulatory requirements.

Disposal

Unused or expired Lorinase should not be flushed down the toilet or sink. The preferred method for disposal is utilizing an authorized drug take-back program. If a take-back option is unavailable, the product may be discarded in the household trash after being mixed with an undesirable substance, such as dirt or used coffee grounds, and sealed in a container.

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

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