Dosage form: tablet
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 10mg, DEXBROMPHENIRAMINE MALEATE 2mg
Labeler: Poly Pharmaceuticals, Inc.
NDC Code: 50991-782
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
(in each tablet)
Dexbrompheniramine Maleate 2 mg
Phenylephrine Hydrochloride 10 mg
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- itching of the nose or throat
- itchy, watery eyes
- nasal congestion
- reduces swelling of nasal passages
Do not exceed recommended dosage.
- 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.
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to enlargement of the prostate gland
- heart disease
- high blood pressure
- thyroid disease
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
- 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
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
|Adults and children 12|
years of age and over:
|1 tablet every 4 to 6
hours, not to exceed
6 tablets in 24 hours
|Children 6 to under 12|
years of age:
|1/2 tablet every 4 to
6 hours, not to
exceed 3 tablets in
|Children under 6 years|
|Consult a doctor
Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Ala-Hist PE Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.
colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD &C Blue #1 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose.
Quitman, MS 39355 Rev. 02/12
The packaging below represents the labeling currently used.
Principal display panel and side panel for 60 tablets label:
Antihistamine • Nasal Decongestant
Each tablet contains:
Dexbrompheniramine Maleate......................2 mg
Phenylephrine Hydrochloride......................10 mg
Usual Dosage: See product foldout for full prescribing information.
Tamper evident by foil seal under cap. Do not use if foil seal is
broken or missing.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.
Store at controlled room temperature between 15°-30°C (59°-86°F).
Quitman, MS 39355
phenylephrine hydrochloride, dexbrompheniramine maleate tablet
|Labeler - Poly Pharmaceuticals, Inc. (198449894)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.