ALA-HIST PE Tablets

ALAHIST PE - dexbrompheniramine maleate and phenylephrine hydrochloride tablet 
Poly Pharmaceuticals, Inc.

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ALA-HIST PE Tablets

DRUG FACTS

ACTIVE INGREDIENTSPURPOSE
Phenylephrine Hydrochloride10 mgDecongestant
Dexbrompheniramine Maleate2mgAntihistamine

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 TypeHUMAN OTC DRUGNDC Product Code (Source)50991-782
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dexbrompheniramine Maleate (Brompheniramine) Dexbrompheniramine Maleate2 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorPURPLEScore2 pieces
ShapeOVALSize11mm
FlavorImprint Code Poly;782
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
150991-782-6060 TABLET In 1 BOTTLE, PLASTICNone
250991-782-0220 TABLET In 1 BLISTER PACKNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/02/2010

Labeler - Poly Pharmaceuticals, Inc. (198449894)
Registrant - Provident Pharmaceuticals, LLC (171901445)
Establishment
NameAddressID/FEIOperations
Provident Pharmaceuticals, LLC171901445MANUFACTURE
Revised: 02/2010Poly Pharmaceuticals, Inc.