Label: CHLORPHENIRAMINE MALEATE 4MG tablet

  • Category: HUMAN OTC DRUG LABEL

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 November 16, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Chlorpheniramine Maleate 4mg

  • INACTIVE INGREDIENT

    D&C yellow #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch

  • DOSAGE & ADMINISTRATION

    • take with a full glass of water
    • do not take more than directed
    adults and children 12 yers of age and over1 tablet every 4 to 6 hours, do not take more than 6 tablets in 24 hours
    children 6 to under 12 years of age1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours
    children under 6 years of age ask a doctor

  • INDICATIONS & USAGE

    temporarily relieves the following 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
    • trouble urinating due to an enlarged prostrate gland

    Ask a doctor or a pharmacist before use if

    you sre taking sedatives or tranquilzers

    When using this product

    • excitability may occur, especially in children
    • drowsiness may occur
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating a machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

    If pregnant or breast-feeding,

    ask a health professional before use

    Keep out of reach of children

    Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • PURPOSE

    Antihistamine

  • OTHER SAFETY INFORMATION

    • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
    • protect from excessive heat and moisture
  • PRINCIPAL DISPLAY PANEL

    CT11341

  • INGREDIENTS AND APPEARANCE
    CHLORPHENIRAMINE MALEATE 4MG 
    chlorpheniramine maleate 4mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-113
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code S72
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-113-414 in 1 PACKAGE; Type 0: Not a Combination Product12/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/20/2018
    Labeler - Strive Pharmaceuticals Inc (080028013)