ALA-HIST IR- dexbrompheniramine maleate tablet 
Poly Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ALA-HIST IR 2 mg Tablets

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:

Warnings

Ask a doctor before use if you have

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

labellabel2

ALA-HIST IR 
dexbrompheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-783
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorgreen (dark green) Score2 pieces
ShapeOVALSize11mm
FlavorImprint Code Poly;783
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-783-0212 in 1 CARTON08/22/2011
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50991-783-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/22/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/22/2011
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 1/2024
Document Id: 0ff22f18-e969-4e15-e063-6294a90a0df5
Set id: 0d203b5c-8b10-428b-8703-17be6b4ce6eb
Version: 9
Effective Time: 20240127
 
Poly Pharmaceuticals, Inc.