Label: CHLORPHENIRAMINE MALEATE 4 MG- chlorpheniramine maleate tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Chlorpheniramine maleate 4 mg

  • Purpose

    Antihistamine

  • Warnings

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

  • GENERAL PRECAUTIONS

    When using this product

    • you may get drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Drug Facts continued on back of label

  • 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 overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 12 years and overtake 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours
    children 6 years to under 12 yearstake 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours
    children under 6 yearsdo not use

  • Other information

    • each tablet contains: calsium 40 mg
    • store at 15°-30°C (59°-86°F)
  • Inactive ingredients

    croscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

  • Questions or comments?

    call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • SPL UNCLASSIFIED SECTION

    * Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Chlor-Trimeton®

    Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

    www.reliable1labs.com

  • Uses

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

    • runny nose
    • sneezing
    • itchy nose or throat
    • itchy, watery eyes
  • HOW SUPPLIED

    NDC: 71335-0963-1: 30 Tablets in a BOTTLE

    NDC: 71335-0963-2: 60 Tablets in a BOTTLE

    NDC: 71335-0963-3: 100 Tablets in a BOTTLE

    NDC: 71335-0963-4: 120 Tablets in a BOTTLE

    NDC: 71335-0963-5: 40 Tablets in a BOTTLE

    NDC: 71335-0963-6: 24 Tablets in a BOTTLE

    Repackaged/Relabeled by:
    Bryant Ranch Prepack, Inc.
    Burbank, CA 91504

  • PRINCIPAL DISPLAY PANEL

    Chlorpheniramine Maleate 4 mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    CHLORPHENIRAMINE MALEATE 4 MG 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0963(NDC:69618-022)
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code AP;016
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-0963-130 in 1 BOTTLE; Type 0: Not a Combination Product10/05/2018
    2NDC:71335-0963-260 in 1 BOTTLE; Type 0: Not a Combination Product05/17/2024
    3NDC:71335-0963-3100 in 1 BOTTLE; Type 0: Not a Combination Product05/17/2024
    4NDC:71335-0963-4120 in 1 BOTTLE; Type 0: Not a Combination Product05/17/2024
    5NDC:71335-0963-540 in 1 BOTTLE; Type 0: Not a Combination Product05/17/2024
    6NDC:71335-0963-624 in 1 BOTTLE; Type 0: Not a Combination Product05/17/2024
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/01/2015
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0963) , RELABEL(71335-0963)
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