Label: ALLERGY TIME- chlorpheniramine maleate tablet

  • NDC Code(s): 49483-242-00, 49483-242-01, 49483-242-10, 49483-242-24
  • Packager: Time Cap Labs Inc
  • 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 December 17, 2018

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg

  • PURPOSE

    Purpose: Antihistamine



  • INDICATIONS & USAGE

    Uses: temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:

    runny nose, sneezing, itching of the nose or throat, itch, watery eyes
  • WARNINGS

    Warnings

    Ask a doctor before use if you have:

    glaucoma; a breathing problem such as emphysema or chronic bronchitis; difficulty urinating due to an enlarged prostate gland
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
  • WHEN USING

    When using this product:

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

    If pregnant or breast-feeding ask a health professional before use.
  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years 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 (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours

    Children under 6 years of age - do not use
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • INACTIVE INGREDIENT

    anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.
  • PRINCIPAL DISPLAY PANEL

    100 CT LABEL

  • INGREDIENTS AND APPEARANCE
    ALLERGY TIME 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-242
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code TCL242
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-242-00100000 in 1 CARTON; Type 0: Not a Combination Product12/17/2018
    2NDC:49483-242-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    3NDC:49483-242-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    4NDC:49483-242-2424 in 1 BLISTER PACK; Type 0: Not a Combination Product12/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/08/2011
    Labeler - Time Cap Labs Inc (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Labs Inc037052099manufacture(49483-242)
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