ALA-HIST PE- phenylephrine hydrochloride, dexbrompheniramine maleate tablet
Poly Pharmaceuticals, Inc.
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.
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ALA-HIST PE TABLETS
Drug Facts
Active ingredients
(in each tablet)
Dexbrompheniramine Maleate 2 mg
Phenylephrine Hydrochloride 10 mg
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, watery eyes
- nasal congestion
- reduces swelling of nasal passages
Warnings
Do not exceed recommended dosage.
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
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
Directions
| 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 24 hours |
| 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. Ala-Hist PE Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.
Inactive ingredients
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.
Product Packaging
The packaging below represents the labeling currently used.
Principal display panel and side panel for 90 tablets label:
NDC 50991-782-90
ALA-HIST PE
Tablets
Antihistamine • Nasal Decongestant
Each tablet contains:
Dexbrompheniramine Maleate......................2 mg
Phenylephrine Hydrochloride......................10 mg
90 Tablets
Usual Dosage: See product foldout for full prescribing information.
Tamper evident by foil seal under cap. Do not use if foil seal isbroken or missing.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.
Store at controlled room temperature between 15°-30°C (59°-86°F).
Manufactured for:
Poly Pharmaceuticals
Rev. 06/19
| ALA-HIST PE
phenylephrine hydrochloride, dexbrompheniramine maleate tablet |
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| Labeler - Poly Pharmaceuticals, Inc. (198449894) |