Label: ALA-HIST IR- dexbrompheniramine maleate tablet

  • NDC Code(s): 50991-783-02, 50991-783-60
  • Packager: Poly Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 27, 2024

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  • 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

    Rev. 02/12

    labellabel2

  • INGREDIENTS AND APPEARANCE
    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)
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