Label: ALLERGY- chlorpheniramine maleate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 3, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient (in each tablet)

    Chlorpheniramine maleate 4 mg

  • Purpose

    Antihistamine

  • Uses

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

    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • Warnings

    Do not use

    to make a child sleepy.

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis  
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

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

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    adults and children 12 years and over1 tablet. Do not exceed 6 tablets in 24 hours.
    children 6 to under 12 years1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
    children under 6 yearsdo not use
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • protect from excessive moisture
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

  • Questions or comments?

    1-800-426-9391

  • HOW SUPPLIED

    Chlorpheniramine Maleate 4 mg

    NDC: 71335-2056-1: 30 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-2056-2: 60 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-2056-3: 100 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-2056-4: 120 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-2056-5: 40 Tablets in a BOTTLE, PLASTIC

    NDC: 71335-2056-6: 24 Tablets in a BOTTLE, PLASTIC

    Repackaged/Relabeled by:

    Bryant Ranch Prepack, Inc.
    Burbank, CA 91504

  • PRINCIPAL DISPLAY PANEL

    Chlorpheniramine Maleate 4 mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-2056(NDC:0904-0012)
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code 44;194
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-2056-130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/02/2022
    2NDC:71335-2056-260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2024
    3NDC:71335-2056-3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2024
    4NDC:71335-2056-4120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2024
    5NDC:71335-2056-540 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2024
    6NDC:71335-2056-624 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/19/1992
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-2056) , RELABEL(71335-2056)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!