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 Type	HUMAN OTC DRUG	NDC Product Code (Source)	50991-783
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dexbrompheniramine Maleate (Brompheniramine)	Dexbrompheniramine Maleate	2 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	GREEN	Score	2 pieces
Shape	OVAL	Size	11mm
Flavor		Imprint Code	Poly;783
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	50991-783-60	60 TABLET In 1 BOTTLE, PLASTIC	None
2	50991-783-02	20 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)

Establishment
Name	Address	ID/FEI	Operations
Provident Pharmaceuticals, LLC		171901445	MANUFACTURE

Revised: 02/2010Poly Pharmaceuticals, Inc.