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

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 20, 2023

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  • Drug Facts

  • Active ingredients (in each chewable tablet)

    Famotidine 10 mg 
    Calcium carbonate 800 mg 
    Magnesium hydroxide 165 mg

    Purposes

    Acid reducer

    Antacid

  • 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 the 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?

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

  • Package Labeling:50269-016-01

    Outer Package2Inner Package2

  • Package Labeling:50269-016-02

    Outer Package3Inner Package3

  • Package Labeling:Inner Package3

    Label

  • INGREDIENTS AND APPEARANCE
    PEPCID COMPLETE 
    famotidine, calcium carbonate, magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50269-016(NDC:16837-298)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE800 mg
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE165 mg
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    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:50269-016-016 in 1 BOX09/01/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50269-016-026 in 1 BOX09/01/2020
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:50269-016-2525 in 1 BOX09/01/2020
    31 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02095809/01/2020
    Labeler - JC World Bell Wholesale Co., Inc. (805257581)
    Establishment
    NameAddressID/FEIBusiness Operations
    Johnson & Johnson Consumer Inc.878046358manufacture(50269-016)
    Establishment
    NameAddressID/FEIBusiness Operations
    JC World Bell Wholesale Co., Inc.805257581repack(50269-016)
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