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

PurposeAntihistamine

UsesFor 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.

DirectionsAdults 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 informationTamper 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 ingredientsdicalcium 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 PackagingThe 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 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: 08/2011
 
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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