ALA-HIST IR

Dosage form: tablet
Ingredients: Dexbrompheniramine Maleate 2mg
Labeler: Poly Pharmaceuticals, Inc.
NDC Code: 50991-783

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.

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:

  • 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
Quitman, MS  39355

Rev. 02/12

ALA-HIST IR 
dexbrompheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-783
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dexbrompheniramine Maleate (Dexbrompheniramine) Dexbrompheniramine Maleate2 mg
Inactive Ingredients
Ingredient NameStrength
Dibasic Calcium Phosphate Dihydrate 
Silicon Dioxide 
Cellulose, Microcrystalline 
Croscarmellose Sodium 
Magnesium Stearate 
Product Characteristics
Colorgreen (dark green) Score2 pieces
ShapeOVALSize11mm
FlavorImprint CodePoly;783
Contains    
Packaging
#Item CodePackage Description
1NDC:50991-783-6060 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/22/2011
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 11/2013
 
Poly Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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