Drug Facts
Active ingredients
(in each tablet)
Dexbrompheniramine Maleate 2 mg
Ala-hist Ir Tablet
FDA Label NDC 50991-783
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Poly Pharmaceuticals, Inc. for the product Ala-hist Ir (NDC 50991-783). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, when using this product, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
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
Label (Alahistir)
Label2 (Alahisir2)
* Please review the disclaimer below.
