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 April 21, 2022

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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 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.1aluminum lake, FD&C red no.40 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearrate, maltodextrin, mineral oil, modified starch, sucralose

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Repackaged and distributed by:
    Select Corporation 1433 Wainwright Way,
    Carrollton, TX 75007, 877-244-4400, M-F 9am-5pm,
    from a product manufactured by
    JOHNSON & JOHNSON CONSUMER INC.

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    McNeil Consumer Healthcare Division
    Fort Washington, PA 19034 USA

  • PRINCIPAL DISPLAY PANEL - 20 Packet Carton

    DUAL ACTION
    Pepcid®
    Complete®
    Acid Reducer + Antacid

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

    Just One Tablet!
    Relieves Heartburn Due
    to Acid Indigestion

    Berry Flavor

    20
    Packets of
    1 Chewable
    Tablet

    PRINCIPAL DISPLAY PANEL - 20 Packet Carton
  • INGREDIENTS AND APPEARANCE
    PEPCID COMPLETE 
    famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-948(NDC:16837-246)
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    corn syrup (UNII: 9G5L16BK6N)  
    crospovidone (120 .mu.m) (UNII: 68401960MK)  
    dextrose, unspecified form (UNII: IY9XDZ35W2)  
    FD&C yellow no. 5 (UNII: I753WB2F1M)  
    aluminum oxide (UNII: LMI26O6933)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    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)  
    triacetin (UNII: XHX3C3X673)  
    cellulose acetate (UNII: 3J2P07GVB6)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize17mm
    FlavorFRUIT (tropical fruit flavor) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-948-031 in 1 BLISTER PACK01/01/2009
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:52904-948-072 in 1 BLISTER PACK01/01/2009
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:52904-948-2020 in 1 CARTON01/01/2009
    31 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:52904-948-2525 in 1 CARTON01/01/2009
    41 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02095801/01/2009
    Labeler - Select Corporation (053805599)
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