Label: PEPCID COMPLETE- famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each chewable tablet)Purposes
    Famotidine 10 mgAcid reducer
    Calcium carbonate 800 mgAntacid
    Magnesium hydroxide 165 mgAntacid
  • Use

    relieves heartburn associated with acid indigestion and sour stomach

  • Warnings

    Allergy alert

    Do not use if you are allergic to famotidine or other acid reducers

    Do not use

    • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
    • with other acid reducers

    Ask a doctor before use if you have

    • had heartburn over 3 months. This may be a sign of a more serious condition.
    • heartburn with lightheadedness, sweating, or dizziness
    • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
    • frequent chest pain
    • frequent wheezing, particularly with heartburn
    • unexplained weight loss
    • nausea or vomiting
    • stomach pain
    • kidney disease

    Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs.

    Stop use and ask a doctor if

    • your heartburn continues or worsens
    • you need to take this product for more than 14 days

    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. (1-800-222-1222)

  • Directions

    • adults and children 12 years and over:
      • do not swallow tablet whole: chew completely
      • to relieve symptoms, chew 1 tablet before swallowing
      • do not use more than 2 chewable tablets in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    • each tablet contains: calcium 320 mg, magnesium 70 mg
    • read the directions and warnings before use
    • keep this carton. It contains important information
    • store at 20°-25°C (68°-77°F)
    • protect from moisture
    • do not use if pouch is torn or damaged
  • Inactive ingredients

    cellulose acetate, corn starch, crospovidone, D&C red no. 7 calcium lake, dextrose excipient, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, modified starch, sucralose

  • Questions or comments?

    call 1-800-755-4008 (toll-free) or 215-273-8755 (collect)

    Distributed by:

    JOHNSON & JOHNSON CONSUMER INC.

    McNeil Consumer Healthcare Division

    For Washington, PA 19034 USA

    Repackaged and distributed by: RJ General

    2024 Northwest Drive, Cincinnati OH 45231

    Do Not Use if the sealed child resistant pouch is broken or torn

  • PRINCIPAL DISPLAY PANEL

    NDC 70264-034-01

    DUAL ACTION
    Pepcid ®
    Complete

    Famotidine 10 mg–Acid reducer
    Calcium carbonate 800 mg–Antacid
    Magnesium hydroxide 165 mg–Antacid

    Just One Tablet!
    Relieves Heartburn Due to Acid Indigestion
    Berry Flavor

    50 Chewable Tablets

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    PEPCID COMPLETE 
    famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70264-034(NDC:16837-298)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE800 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE165 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    ACACIA (UNII: 5C5403N26O)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeROUNDSize18mm
    FlavorBERRYImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70264-034-0150 in 1 CARTON; Type 0: Not a Combination Product12/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02095801/09/2022
    Labeler - R J General Corporation (122542830)
    Establishment
    NameAddressID/FEIBusiness Operations
    R J General Corporation122542830repack(70264-034)
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