ALA-HIST IR - 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 IR 2 mg Tablets

Drug Facts

Active ingredients
Dexbrompheniramine Maleate..............2 mg

Purpose

Antihistamine

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.

Warnings

When using this product it 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. 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.

Directions

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).

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

Inactive ingredients

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

Questions?

Call (800) 882-1041

Manufactured for:
Poly Pharmaceuticals
Quitman, MS 39355

Rev. 06/11

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-783-60 60 Tablets

ALA-HIST IR
2 mg Tablets

Antihistamine

Each tablet contains:
Dexbrompheniramine Maleate.........2 mg

Usual Dosage: See product foldout for full
prescribing information.

KEEP THIS AND ALL DRUGS OUT OF THE
REACH OF CHILDREN.

Store at controlled room temperature 15°-30°C
(59°-86°F).

Manufactured for:
Poly Pharmaceuticals
Quitman, MS 39355

Rev. 06/11

ALA-HIST IR
dexbrompheniramine maleate tablet

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

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

Ingredient Name	Strength
Inactive Ingredients
Dibasic Calcium Phosphate Dihydrate
Silicon Dioxide
Cellulose, Microcrystalline
Croscarmellose Sodium
Magnesium Stearate

Product Characteristics
Color	green (dark green)	Score	2 pieces
Shape	OVAL	Size	11mm
Flavor		Imprint Code	Poly;783
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50991-783-60	60 in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/22/2011

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 8/2011

Document Id: 2c258e61-72b9-4a23-a95b-8651e8ff023a

Set id: 0d203b5c-8b10-428b-8703-17be6b4ce6eb

Version: 2

Effective Time: 20110825

Poly Pharmaceuticals, Inc.