Ala-Hist PE

Quick links to important sections

Ala-Hist PE

Treatment option:

Medically reviewed

Rosario Oropesa

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 Ala-Hist PE

Ala-Hist PE is a synthetic Compound classified as an Antihistamine-Decongestant Combination product, formulated for oral administration. This therapeutic agent provides dual action against common upper respiratory symptoms.


Quick Facts Overview

Property Description
Active Ingredients Dexbrompheniramine maleate & Phenylephrine Hydrochloride
Common Forms Tablet, Capsule, Oral liquid
Pharmacological Class Antihistamine-Decongestant Combination
Origin Synthetic Compound
General Purpose Provides symptomatic relief for allergic and congestive symptoms

What Type of Medicine is Ala-Hist PE?

The medicine is a fixed-dose combination utilizing two distinct active ingredients to simultaneously target different physiological processes. The antihistamine component, Dexbrompheniramine maleate, is an H1-receptor antagonist that works against the effects of histamine released during allergic reactions. The decongestant component, Phenylephrine Hydrochloride, is classified as a nasal decongestant, working to reduce swelling in the nasal passages.

This specific combination is clinically recognized for managing the concurrent symptoms of allergic rhinitis, providing relief for these manifestations. This formulation is often differentiated in the market by its inclusion of Dexbrompheniramine, an ingredient that provides effective antihistamine effects.


Composition and General Therapeutic Purpose

The core composition ensures that symptoms driven by the body's overreaction (like itching and secretions) are controlled by the antihistamine, while the physical discomfort of a blocked nose (nasal congestion) is alleviated by the decongestant. This synthetic compound is typically supplied for oral administration in pharmaceutical preparations such as a tablet or capsule, and sometimes as an oral liquid formulation.

The overall function of Ala-Hist PE is to provide comprehensive symptomatic relief for the concurrent symptoms that arise from allergic rhinitis or the common cold. This integrated approach aims to restore a sense of clearer breathing and reduce the generalized discomfort associated with these upper respiratory conditions, making it a suitable therapeutic choice for individuals experiencing both congestion and allergic manifestations.

What side effects are possible with Ala-Hist PE?

Possible Side Effects and Safety Information

The official regulatory profile for Ala-Hist PE, a combination of Dexbrompheniramine maleate and Phenylephrine Hydrochloride, details adverse reactions primarily affecting the nervous and cardiovascular systems. The U.S. regulatory label lists effects that may occur but does not use standard frequency classifications (e.g., common, uncommon).


Documented Adverse Reactions

The documented adverse reactions are associated with the following System-Organ Classes:

  • Nervous System Disorders: Drowsiness, dizziness, headache, sleeplessness, and nervousness are documented.
  • Gastrointestinal Disorders: Effects include dry mouth, dry nose, dry throat, upset stomach, and constipation.
  • Cardiac Disorders: Fast or irregular heartbeats are listed as a possible effect.

Clinically Significant and Serious Reactions

The label identifies certain reactions that necessitate immediate attention, including signs of a severe allergic reaction (such as swelling of the face or throat), seizure, hallucinations, confusion, and pronounced fast or irregular heartbeats.

Safety Constraints and Considerations

Official labeling mandates that use requires consultation with a health professional for individuals with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or chronic breathing problems.

Population-Specific Notes: Excitability may occur, specifically noted in children. For pregnant or breastfeeding individuals, consultation with a health professional is required, as the medicine's components may slow breast milk production.

Drug Interaction Constraint: Use is prohibited if the individual is currently taking a Monoamine Oxidase Inhibitor (MAOI) or for two weeks after stopping an MAOI. Furthermore, the effects of alcohol, sedatives, and tranquilizers may be increased by this medicine.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documentation states that overdosage with Ala-Hist PE, an Antihistamine-Decongestant Combination product, can result in severe and potentially life-threatening manifestations. The recognized clinical presentation reflects the combined toxicity of Dexbrompheniramine and Phenylephrine.

Documented Overdose Manifestations

Overdose may present with contradictory effects on the Central Nervous System, including profound CNS depression (e.g., somnolence, stupor) and paradoxical CNS excitation (e.g., hallucinations, restlessness, seizures). Anticholinergic signs such as mydriasis, hyperpyrexia, and flushed skin are documented, along with severe cardiovascular risks, including hypertension, tachycardia, and arrhythmias.

Severe Outcomes and Emergency Actions

Life-threatening outcomes cited in regulatory texts include seizures, respiratory depression, and cardiovascular collapse. Due to the severity of these documented risks, official labeling explicitly mandates that immediate medical attention must be sought for any suspected overdose. Individuals must contact emergency services or a Poison Control Center immediately. Treatment is described as symptomatic and supportive, and official documents specify that no specific antidote is known. Hospital monitoring with continuous ECG monitoring is required until the patient's condition stabilizes. The pediatric population is cited as being at increased risk for CNS excitation and seizures.

Therapeutic Uses of Ala-Hist PE

Main Uses of Ala-Hist PE

Ala-Hist PE is a combination medication designed to address symptoms associated with the common cold, hay fever, and other upper respiratory allergies. It contains two primary active components: an antihistamine and a nasal decongestant. This combination is intended to provide temporary relief from multi-symptom respiratory discomfort.

Relief of Allergy and Cold Symptoms

The antihistamine component of Ala-Hist PE targets the underlying biological response to allergens. When the body encounters substances like pollen, dust mites, or pet dander, it releases histamine, which leads to various physical symptoms. Ala-Hist PE helps manage these reactions, specifically addressing:

  • Sneezing: Reducing the frequency of sudden, repetitive sneezing episodes.
  • Itchy Nose and Throat: Calming the irritation often felt in the nasal passages and the back of the throat.
  • Watery Eyes: Decreasing the excessive tearing and itching of the eyes caused by environmental triggers.

Nasal and Sinus Decongestion

The decongestant ingredient in Ala-Hist PE focuses on the swelling of the nasal passages. During a cold or an allergic flare-up, blood vessels in the nose become dilated, leading to a feeling of "stuffiness."

  • Nasal Congestion: The medication works to shrink swollen membranes, making it easier to breathe through the nose.
  • Sinus Pressure: By reducing swelling in the nasal passages, the medication may help alleviate the feeling of pressure and fullness within the sinuses.

Benefits of the Combination Formula

The primary benefit of Ala-Hist PE is its ability to address both secretory symptoms (like sneezing and runny nose) and obstructive symptoms (like nasal congestion) simultaneously. By combining an antihistamine with a decongestant, the formulation provides a broader range of symptom management than single-ingredient products might offer for individuals experiencing complex respiratory congestion.

Regulatory References

  1. DailyMed overview

Eligibility and Restrictions for Use

The official eligibility profile for Ala-Hist PE, an Antihistamine-Decongestant Combination, defines specific populations who must avoid the medication and others who require medical consultation prior to use.

Eligibility Constraints

Populations for whom use is contraindicated include those taking a Monoamine Oxidase Inhibitor (MAOI) or who have stopped taking one within the last 14 days. Individuals with known hypersensitivity to the active ingredients are also ineligible.

Use is conditionally restricted for patients with pre-existing conditions such as high blood pressure, heart disease, diabetes, glaucoma, thyroid disease, or difficulty urinating due to an enlarged prostate. These groups must consult a health professional.

Age-related eligibility permits standard use for adults and children 12 years and older, while children under 6 years must consult a doctor. Older adults should use the medicine with caution due to greater sensitivity. The label mandates that pregnant and breastfeeding patients must ask a health professional before use. These constraints ensure use remains strictly aligned with governmental regulatory guidelines.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Ala-Hist PE’s official interaction profile establishes an absolute regulatory prohibition on combining the medicine with Monoamine Oxidase Inhibitors (MAOIs). This combination is formally classified as contraindicated due to the potential for a dangerous drug interaction, including the risk of hypertensive crisis related to the Phenylephrine component. To enforce this restriction, a mandatory timing rule states that the medicine must not be used for at least two weeks after stopping any MAOI therapy.

Pharmacodynamic interactions are documented primarily through additive effects. Co-administration with CNS Depressants—including prescription sedatives, tranquilizers, opioid relievers, alcohol, and Marijuana (Cannabis)—may result in additive CNS depressant effects. Additive effects are also noted with Anticholinergic Agents, such as antihistamines applied to the skin.

The profile also highlights Sympathomimetic and Pressor Reinforcement: combination with other Sympathomimetics or Oxytocic Drugs may lead to a reinforcement of the pressor effect of the decongestant component. An interaction is noted where Acetaminophen may increase the systemic serum concentrations of Phenylephrine, officially modifying exposure. Furthermore, consumption of caffeine-containing foods or beverages may cause additive CNS-stimulant actions.

Mechanism of Action

How Ala-Hist PE Works

Ala-Hist PE exerts its action through two distinct pharmacodynamic mechanisms: histamine H1 receptor antagonism and alpha-adrenergic agonism. These actions modulate pathways associated with heightened reactivity in various physiological systems, resulting in targeted cellular adjustments.


H1 Receptor Antagonism

This component involves the competitive inhibition of histamine binding to the H1 receptor. Histamine, an endogenous signaling molecule, typically initiates intracellular cascades that lead to increased vascular permeability and smooth muscle contraction. By blocking this receptor, the drug interrupts the downstream signaling sequences and modifies subsequent physiological responses in target tissues following mediator release.


alpha-Adrenergic Agonism

This mechanism centers on the selective activation of alpha1-adrenergic receptors on the surface of specific smooth muscle cells. This receptor-mediated signaling triggers a G-protein-coupled pathway, ultimately leading to the constriction of small blood vessels (vasoconstriction). This effect alters local blood flow and modifies molecular steps that influence vascular tone.

Dosage and Administration Information

Official Administration Instructions

Ala-Hist PE is formulated in a 2 mg dexbrompheniramine maleate and 7.5 mg phenylephrine hydrochloride tablet strength. This medication is intended for oral administration.


Standard Labeled Dosing Regimens

Age Group Unit Dose Frequency Maximum Daily Dose (24 Hours)
Adults and Children 12 years and older 1 tablet Every 4 hours 6 tablets
Children 6 to under 12 years 1/2 tablet Every 4 hours 3 tablets
Children under 6 years Consult a doctor Not applicable Not applicable

All doses should adhere to the established frequency and maximum daily limits.


Procedural and Course Constraints

The tablet is scored to assist in the preparation of the half-tablet dose for children aged 6 to under 12 years. The medication can be taken with or without food. This product is intended for temporary relief; if symptoms persist or do not show improvement within 7 days, use of the product should be discontinued. It is important to follow the age-specific dosing rules and not exceed the recommended dosage.

Recent Clinical Evidence

Ala-Hist PE: Recent Clinical Evidence

Evidence for Symptom Clusters Associated with Allergic Rhinitis (Hay Fever)

Clinical research for Ala-Hist PE includes short-term Randomized Controlled Trials (RCTs) and systematic reviews that explore symptom changes in conditions characterized by fluctuating or episodic manifestations. Studies examine patient-reported outcomes for symptoms like sneezing, runny nose, and itching. The antihistamine component is part of a long-established regulatory class, but the overall evidence structure is complex because inconsistent measurements were recorded for the decongestant component included in the fixed dose. Follow-up durations were limited, typically spanning only five to seven days, providing little insight into long-term effects.


Evidence for Acute Nasal Congestion Relief

Research examined the decongestant component through acute, single-dose RCTs and subsequent meta-analyses, focusing on outcomes related to physical discomfort such as nasal stuffiness. These studies used objective measures of air flow alongside subjective patient scores. Multiple recent reviews reported that the measured outcome on nasal congestion was frequently observed to be statistically similar to placebo at common doses. This suggests uncertainty remains high regarding the decongestant component, with inconsistent patterns noted across numerous high-quality trials.


Long-Term Studies and Follow-up Duration

Clinical trials generally examine short-term symptom changes with limited follow-up, spanning only a few hours to seven days. The findings describe group patterns, not personal outcomes, and long-term effects are not fully established or well characterized.


Evidence in Special Populations

The primary body of evidence focused on adults presenting with symptoms. Data for certain groups remain insufficient, as specific studies involving older adults or patients with complex issues were generally excluded. Furthermore, there is limited data for the use of this fixed combination in children.


Evidence Gaps and Areas of Uncertainty

A central gap arises from the inconsistent patterns concerning the oral decongestant component's outcomes, with limited evidence indicating measured outcomes were reliably distinguishable from placebo. Follow-up durations were limited, and subgroup findings are uncertain for specific age brackets.

Key Studies & References DailyMed - Ala-Hist PE (Dexbrompheniramine Maleate and Phenylephrine Hydrochloride) extended release tablet

Frequently Asked Questions (FAQ)

Common questions about Ala-Hist PE (FAQ)


Q: Is it normal to feel a mild 'shaky' or nervous feeling after taking this medicine?

Official regulatory documents indicate that nervousness is a possible adverse reaction that may occur with this medication. If nervousness, dizziness, or sleeplessness occur, the labeling advises that you should discontinue use and consult a healthcare professional. This information is provided in the official label to guide users regarding possible adverse reactions.


Q: Are there specific vitamins or supplements that are known to interact with Ala-Hist PE?

Regulatory documents list specific interactions with substances like alcohol, sedatives, tranquilizers, and Monoamine Oxidase Inhibitors (MAOIs). While vitamins or general supplements are not typically itemized, official labeling generally advises consulting a health professional before combining this product with nonprescription drugs or herbal products. This consultation is part of the established safety constraints when using the product.


Q: Does Ala-Hist PE contain pseudoephedrine?

No, the product does not contain pseudoephedrine. According to the Drug Facts section of the official labeling, the active ingredients are Dexbrompheniramine maleate (an antihistamine) and Phenylephrine Hydrochloride (a decongestant).


Q: If I miss a dose of Ala-Hist PE, what is the general guidance on what to do next?

General consumer information often describes the approach for a missed dose, which is typically to take it as soon as it is remembered. However, if it is near the time of the next scheduled dose, general guidance indicates that the missed dose is usually skipped. The instructions emphasize that the dose is not to be doubled.


Q: Can I take Ala-Hist PE with my regular morning coffee?

Official regulatory labeling includes a warning that consuming caffeine-containing foods or beverages may cause additive stimulant actions when combined with this medicine. The labeling advises caution, as combining the product with caffeinated drinks may lead to additive stimulant effects.


Q: What is the primary benefit of taking Ala-Hist PE compared to a single-ingredient decongestant?

Ala-Hist PE is a fixed-dose combination product that contains both an antihistamine and a decongestant. The primary benefit, as indicated in regulatory documents, is the ability to provide temporary relief for both allergic symptoms (such as sneezing and itching) and nasal congestion simultaneously.


Q: Is the antihistamine component of Ala-Hist PE the same as Benadryl?

No, the active antihistamine ingredient in Ala-Hist PE is Dexbrompheniramine maleate. This is a different chemical entity from the antihistamine in the product commonly sold under the brand name Benadryl, which is Diphenhydramine.


Q: What is the evidence supporting the combination of ingredients in Ala-Hist PE?

The combination of the antihistamine and the decongestant is indicated in official labeling for the temporary relief of symptoms associated with allergic rhinitis and the common cold. The regulatory approval of this fixed-dose combination supports its intended use for managing these co-occurring symptoms.


Q: How quickly do the effects of Ala-Hist PE typically begin to be felt?

The decongestant component, Phenylephrine, typically begins to exert its action within 15 to 30 minutes following oral administration. Symptomatic relief may vary.


Q: What is the usual duration of action for a single dose of Ala-Hist PE?

Official administration instructions for this product generally specify dosing every 4 hours. This frequency aligns with the established duration of action for the Phenylephrine component in the oral form, which is typically between two and four hours.


Q: Is Ala-Hist PE considered safe to take every day for an extended period?

Official labeling documents emphasize that this product is intended only for temporary relief of symptoms. It is directed that if symptoms persist or do not improve within 7 days, use of the product should be stopped, and a health professional should be consulted. The product is intended only for temporary use, according to official directions.


Q: Are there published research findings about Ala-Hist PE for non-allergy related congestion?

Official product labeling indicates that this medicine is intended for the temporary relief of symptoms due to the common cold in addition to upper respiratory allergies. The indication for the common cold covers congestion that is not exclusively related to allergic causes.


Q: Does the medicine lose effectiveness if used continuously over several weeks?

Since regulatory instructions advise stopping use after 7 days if symptoms persist, the product is not intended for continuous use over several weeks. Therefore, the issue of potential loss of effectiveness or tolerance with prolonged, unadvised use is not addressed in standard labeling.


Q: Can older adults use Ala-Hist PE without adjustment?

Official labeling mandates that older adults should consult a doctor before using this product, as they may be more sensitive to its effects. While the standard dosing frequency for adults may be listed, the official guidance for this population requires consultation with a health professional before use.


Q: Can people with kidney problems use Ala-Hist PE safely?

Although kidney disease may not be specifically listed on all product labels, authoritative medical sources generally advise patients with kidney problems to consult a doctor before using medications that contain antihistamines or decongestants. This consultation is often suggested because dosage modifications may be necessary in the context of existing kidney conditions.


Q: Is Ala-Hist PE a prescription medicine or available over-the-counter?

Ala-Hist PE is classified by regulatory authorities as an Over-the-Counter (OTC) medicine. The classification indicates it is available without needing a doctor's prescription.


Q: Why is the drug sometimes mentioned in discussions about athletic competition and doping?

The decongestant component of Ala-Hist PE, Phenylephrine, belongs to a pharmacological class known as sympathomimetics. Certain sympathomimetics are included on the World Anti-Doping Agency (WADA) Prohibited List. Official recommendations state that athletes should check with their relevant sports authority regarding the status of this specific ingredient.


Q: Do studies show Ala-Hist PE being examined for nasal congestion caused by non-allergic rhinitis?

Official indications for this product include the temporary relief of symptoms due to the common cold and upper respiratory allergies. Non-allergic rhinitis is a specific diagnosis; however, the product’s indications include general relief for congestion associated with the common cold.

How should Ala-Hist PE be stored and disposed of?

How to Store and Dispose of Ala-Hist PE

Ala-Hist PE tablets must be stored at Controlled Room Temperature, which is officially defined as a temperature range of 15° to 30°C (59° to 86°F). Proper storage is essential to maintain the product's stability and quality.


Storage Requirements

Requirement Official Instruction
Temperature Store at 15° to 30°C (Controlled Room Temperature)
Container Keep in the original tight, light-resistant container with a child-resistant cap
Child Safety KEEP OUT OF REACH OF CHILDREN

Disposal Guidance

If the official labeling does not contain specific instructions for discarding unused or expired Ala-Hist PE, disposal should follow general guidelines for discarding unused medications. In the event of an overdose, contact a Poison Control Center or seek medical help immediately.

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

Available in countries:

Equivalent of Ala-Hist PE found in:

A-Z Index: