Label: ALA-HIST PE- phenylephrine hydrochloride, dexbrompheniramine maleate tablet

  • NDC Code(s): 50991-782-02, 50991-782-90
  • Packager: Poly Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 11, 2019

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredients
    (in each tablet)

    Dexbrompheniramine Maleate 2 mg
    Phenylephrine Hydrochloride 10 mg

  • Purpose

    Antihistamine
    Nasal Decongestant

  • Uses

    Temporarily 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 information

    Store 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 ingredients

    colloidal 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

    Huntsville, AL

  • Product Packaging

    The packaging below represents the labeling currently used.

    Principal display panel and side panel for 90 tablets label:

    NDC 50991-782-90

    ALA-HIST PE



    Tablets

    Antihistamine • Nasal Decongestant

    Each tablet contains:



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



    Phenylephrine Hydrochloride......................10 mg

    90 Tablets

    Usual Dosage: See product foldout for full prescribing information.

    Tamper evident by foil seal under cap. Do not use if foil seal isbroken 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

    Rev. 06/19

    label

    full

  • INGREDIENTS AND APPEARANCE
    ALA-HIST PE 
    phenylephrine hydrochloride, dexbrompheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-782
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    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
    Colorpurple (dark purple) Score2 pieces
    ShapeOVAL (caplet-shaped) Size11mm
    FlavorImprint Code Poly;782
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50991-782-0212 in 1 CARTON09/15/2011
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50991-782-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/15/2011
    Labeler - Poly Pharmaceuticals, Inc. (198449894)