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Name:Alahist Pe
Manufacturer:Poly Pharmaceuticals, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


ALA-HIST PE Tablets

ALAHIST PE - dexbrompheniramine maleate and phenylephrine hydrochloride 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 PURPOSE
Phenylephrine Hydrochloride 10 mg Decongestant
Dexbrompheniramine Maleate 2mg Antihistamine

DESCRIPTION

Ala-Hist PE Tablets are purple, caplet-shaped, scored tablets, debossed Poly 782.

USES

Temporarily relieves nasal congestion due to the common cold.

DRUG INTERACTION PRECAUTION

Do not use 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.

WARNINGS

Do not exceed recommended dosage. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product.

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery. If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. Do not take this product if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

If pregnant or breast feeding, ask a health professional before use.

Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENTS

dicalcium phosphate dihydrate, silicon dioxide, microcrystalline cellulose, croscarmellose, purple dye, and magnesium stearate.

DOSING

Adults and children 12 years of age and older: 1 tablet every 4-6 hours, not to exceed 6 tablets in a 24 hour period. Children 6 to 12 years of age: half tablet every 4-6 hours, not to exceed 3 tablets in a 24 hour period. Children 6 years of age and younger: Consult a physician.

OTHER INFORMATION

Tamper evident: do not use if tamper evident seal is broken or missing. Store at 15°-30°C (59°-86°F).

QUESTIONS?

Call (601)776-3497

Manufactured for:
Poly Pharmaceuticals
Quitman, MS 39355

Manufactured by:
Provident Pharmaceuticals, LLC
Colorado Springs, CO 80919

PI 396

Rev. 12/09

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

NDC 50991-782-60

60 Tablets

ALA-HIST PE
Tablets

Decongestant • Antihistamine

Each tablet contains:
Phenylephrine Hydrochloride ...... 10 mg
Dexbrompheniramine Maleate ....... 2mg

FOR PROFESSIONAL USE ONLY

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

ALAHIST PE 
dexbrompheniramine maleate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50991-782
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dexbrompheniramine Maleate (Brompheniramine) Dexbrompheniramine Maleate 2 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg
Product Characteristics
Color PURPLE Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code Poly;782
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50991-782-60 60 TABLET ( TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:50991-782-02 20 TABLET ( TABLET) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 02/02/2010

Labeler - Poly Pharmaceuticals, Inc. (198449894)
Registrant - Provident Pharmaceuticals, LLC (171901445)
Establishment
Name Address ID/FEI Operations
Provident Pharmaceuticals, LLC 171901445 MANUFACTURE

Revised: 02/2010 Poly Pharmaceuticals, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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