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FDA LABEL GENERIC: Dexbrompheniramine MFR: Poly Pharmaceuticals, Inc.

Ala-hist Ir 2 Mg Oral Tablet

Drug Facts

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or upper respiratory allergies:

runny nose sneezing itching of the nose or throat itchy, watery eyes

Warnings

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery

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

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children
12 years of age and
over:
1 tablet every 4 to 6
hours, not to exceed
6 tablets in 24 hours.
Children 6 to under
12 years of age: 
1/2 tablet every 4 to 6 
hours, not to exceed
3 tablets in 24 hours. 
Children under 6
years of age: 
Consult a doctor. 

Other information

Store at 15° - 30°C (59° - 86°F).

Supplied in a tight, light-resistant container with a child-resistant cap.

Contains color additives including FD&C Yellow No. 5 (tartrazine).

Ala-Hist IR Tablets are dark green caplet shaped, scored tablets, debossed "Poly" bisect "783" on one side and plain on the other.

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 aluminum lake, FD&C Yellow #5 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose.

Questions?

Call 1-800-882-1041

Manufactured for:
Poly Pharmaceuticals
Quitman, MS  39355

Rev. 02/12

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-783-60



ALA-HIST IR

2 mg Tablets

Antihistamine

Each tablet contains:

Dexbrompheniramine Maleate.........2 mg

60 Tablets

Usual Dosage: See product foldout for full

prescribing information

Tamper evident by foil seal under cap. Do not

use if foil seal is broken or missing.

KEEP THIS AND ALL DRUGS OUT OF

REACH OF CHILDREN.

Store at controlled room temperature 15°-30°C

(59°-86°F).

Manufactured for:

Poly Pharmaceuticals

Rev. 02/12