Active Ingredients
(in each tablet)
Dexbrompheniramine Maleate 2 mg
Phenylephrine Hydrochloride 7.5 mg
Alahist Pe Tablet
FDA Label NDC 50991-788
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Poly Pharmaceuticals, Inc. for the product Alahist Pe (NDC 50991-788). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, do not use this product, ask a doctor before use if you have, when using this product, stop use and ask doctor if, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Dexbrompheniramine Maleate- -Antihistamine
Phenylephrine Hydrochloride-- Nasal Decongestant
Uses
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, water eyes
- nasal congestion
- reduces swelling of nasal passages
Do Not Use This Product
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to enlargement of the prostate gland
- heart disease
- high blood pressure
- thyroid disease
- diabetes
Ask a doctor or pharmacist before use if you are taking
sedatives or tranquilizers.
When Using This Product
- excitability may occur, especially in children
- may cause drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask Doctor If
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
If Pregnant Or Breastfeeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
| Adults and children 12 years of age and over: | 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor. |
| Children 6 to under 12 years of age | 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor. |
| Children under 6 years of age: | Consult a doctor. |
Other Information
Store at 15°-30°C (59°-86°F). Supplied in a tight,light-resistant container with a child-resistant cap. Alahist PE Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.
Inactive Ingredients
Croscarmellose sodium, D&C Red # 27 aluminum lake, FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide
Questions? Comments?
Call 1-800-882-1041
Alahist Pe Label
Manufactured for
Poly Pharmaceuticals
Huntsville, AL 35763
Label (Alahistpe)
Back (Alahistpeback)
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