Label: CHLORPHENIRAMINE MALEATE 4 MG- 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 February 14, 2022

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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

  • PRINCIPAL DISPLAY PANEL

    Chlorpheniramine Maleate 4mg 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 Product02/14/2022
    3NDC:71335-0963-3100 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    4NDC:71335-0963-4120 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    5NDC:71335-0963-540 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/01/2015
    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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