Label: CLEAR CHOICE ALLERGY RELIEF- chlorpheniramine maleate tablet

  • 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 November 7, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Chlorpheniramine Maleate 4 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    USES: Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies, sneezing, runny nose, itchy, watery eyes, itchy nose or throat

  • WARNINGS

    Warnings:

  • ASK DOCTOR

    Ask a doctor before use if you have

    a breathing problem such as emphysema or chronic bronchitis

    glaucoma or

    trouble urinating due to enlargement of the 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

    marked drowsiness may occur

    avoid alcoholic beverages

    alcohol, sedatives, and tranquilizers may increase drowsiness

    be careful when driving a motor vehicle or operating machinery

    excitability may occur especially in children

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions

    • take every 4 to 6 hours,
    • do not take more than 6 does 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
  • STORAGE AND HANDLING

    Other Information

    store at room temperature in a dry place

    do not use if imprinted safety seal under cap is broken or missing.

  • INACTIVE INGREDIENT

    Inactive Ingredients: dicalcium phosphate, D&C yellow # 10 aluminum lake, lactose, magnesium stearate, microcrystalline
    cellulose, stearic acid.

  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Schering-Plough, owner of the registered trademark Chlor-Trimeton(R).

  • QUESTIONS

    To Report Adverse Drug Events, call 1-888-952-0050

    Questions? Contact A.N.I. Toledo, Ohio

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    A.N.I. Toledo, OH 43623

  • PRINCIPAL DISPLAY PANEL

    Clear Choice

    ALLERGY RELIEF

    Antihistamine Chlorpheniramine Maleate

    4 Hour

    RELIEVES: SNEEZING, WATERY EYES, ITCHY THROAT, RUNNY NOSE

    Compare to Chlor-Trimeton(R)

    24 Tablets

    4 mg Each

    allergy relief label
  • INGREDIENTS AND APPEARANCE
    CLEAR CHOICE ALLERGY RELIEF 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53185-001
    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)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Coloryellow (yellow) Scoreno score
    ShapeROUND (round) Size8mm
    FlavorImprint Code AZ246
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53185-001-2424 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/23/2012
    Labeler - Athlete's Needs Inc (619703945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930manufacture(53185-001)
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