ALA-HIST PE

Dosage form: tablet
Ingredients: Phenylephrine Hydrochloride 10mg, Dexbrompheniramine Maleate 2mg
Labeler: Poly Pharmaceuticals
NDC Code: 50991-782

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 PE TABLETS

Drug Facts Active ingredients
(in each tablet)
Dexbrompheniramine Maleate 2 mg
Phenylephrine Hydrochloride 10 mg

PurposeAntihistamine
Nasal Decongestant

UsesTemporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • reduces swelling of nasal passages

Warnings Do not exceed recommended dosage.

Do not use this product
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.  If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

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

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever

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 informationStore at 15° - 30°C (59° - 86°F).  Supplied in a tight, light-resistant container with a child-resistant cap.  Ala-Hist PE Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.

Inactive ingredientscolloidal silicon dioxide, croscarmellose sodium, D&C Red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD &C Blue #1 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose.

Questions? Comments?Call1-800-882-1041

Manufactured for:
Poly Pharmaceuticals
Quitman, MS  39355                    Rev. 02/12

Product PackagingThe packaging below represents the labeling currently used.

Principal display panel and side panel for 60 tablets label:

NDC 50991-782-60

ALA-HIST PE
Tablets


Antihistamine • Nasal Decongestant

Each tablet contains:
Dexbrompheniramine Maleate......................2 mg
Phenylephrine Hydrochloride......................10 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 between 15°-30°C (59°-86°F).

Manufactured for:
Poly Pharmaceuticals
Quitman, MS  39355

Rev. 02/12



ALA-HIST PE 
phenylephrine hydrochloride, dexbrompheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-782
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride10 mg
Dexbrompheniramine Maleate (Dexbrompheniramine) Dexbrompheniramine Maleate2 mg
Inactive Ingredients
Ingredient NameStrength
Dibasic Calcium Phosphate Dihydrate 
Silicon Dioxide 
Cellulose, Microcrystalline 
Croscarmellose Sodium 
Magnesium Stearate 
Product Characteristics
Colorpurple (dark purple) Score2 pieces
ShapeOVAL (caplet-shaped) Size11mm
FlavorImprint CodePoly;782
Contains    
Packaging
#Item CodePackage Description
1NDC:50991-782-6060 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/15/2011
Labeler - Poly Pharmaceuticals (198449894)
Registrant - Pernix Manufacturing, LLC (078641814)
Establishment
NameAddressID/FEIOperations
Pernix Manufacturing, LLC dba Great Southern Laboratories078641814manufacture(50991-782)

Revised: 02/2013
 
Poly Pharmaceuticals

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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