ALA-HIST IR Tablets 2 mg

ALAHIST IR - dexbrompheniramine maleate tablet 
Poly Pharmaceuticals, Inc.

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ALA-HIST IR Tablets 2 mg

DRUG FACTS

ACTIVE INGREDIENTS

Dexbrompheniramine Maleate .... 2 mg

PURPOSE

Antihistamine

DESCRIPTION

Ala-Hist IR Tablets are dark green caplet shaped, scored tablets, debossed Poly 783.

USES

For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other respiratory allergies.

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, green 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 395

Rev. 12/09

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

NDC 50991-783-60

60 Tablets

ALA-HIST IR
2 mg Tablets

Antihistamine

Each tablet contains:
Dexbrompheniramine Maleate .. 2 mg

FOR PROFESSIONAL USE ONLY

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

ALAHIST IR 
dexbrompheniramine maleate   tablet
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)50991-783
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dexbrompheniramine Maleate (Brompheniramine) Dexbrompheniramine Maleate2 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorGREENScore2 pieces
ShapeOVALSize11mm
FlavorImprint Code Poly;783
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
150991-783-6060 TABLET In 1 BOTTLE, PLASTICNone
250991-783-0220 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)
Establishment
NameAddressID/FEIOperations
Provident Pharmaceuticals, LLC171901445MANUFACTURE
Revised: 02/2010Poly Pharmaceuticals, Inc.