Label: ALLERGY- chlorpheniramine maleate tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2016

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  • Active ingredient

    Chlorpheniramine Maleate 4 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    ■ sneezing

    ■ runny nose

    ■ itchy watery eyes

    ■ itching of the nose or throat

  • Warnings

    Ask a doctor before use if you have

    ■ a breathing problem such as emphysema or chronic bronchitis

    ■ glaucoma or

    ■ trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you

    are taking sedatives or tranquilizers

    When using this product

    ■ marked drowsiness may occur

    ■ avoid alcoholic beverages

    ■ alcohol, sedatives, and tranquilizers may increase drowsiness

    ■ be careful when drivinga motor vehicle or operating machinery 

    ■ excitability may occur especially in children

    Pregnancy/Breastfeeding

    ask a health professional before use.

    Keep out of reach of children

    In case of accidental overdose, contact a doctor or Poison Control Center immediately.

  • Directions

    ■ take every 4 to 6 hours

    ■ do not take more than 6 doses in 24 hours

    ■ Adults and children 12 years and over: 1 tablet

    ■ Children 6 to under 12 years: 1/2 tablet

    ■ Children under 6 years: consult a doctor

  • Other information

     ■ Store at room temperature in a dry place

  • Inactive ingredients

    D&C Yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid. May contain starch.

  • Principal Display Panel

     Allergy Relief

    Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    chlorpheniramine maleate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-277
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code AZ;246
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-277-931 in 1 CARTON12/15/2014
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/15/2014
    Labeler - Marc Glassman, Inc. (094487477)
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