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

  • NDC Code(s): 16837-298-12, 16837-298-25, 16837-298-50, 16837-298-65, view more
    16837-298-67, 16837-298-68
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 19, 2020

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

  • 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
    • read the bottle. It contains important information.
    • store at 20°-25°C (68°-77°F)
    • protect from moisture
    • do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing
  • 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)

  • PRINCIPAL DISPLAY PANEL

    NDC 16837-298-25
    See New Warnings

    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

    actual size

    25 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: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 (15 MPA.S AT 5%) (UNII: 68401960MK)  
    dextrose, unspecified form (UNII: IY9XDZ35W2)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    aluminum oxide (UNII: LMI26O6933)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    D&C Red No. 7 (UNII: ECW0LZ41X8)  
    acacia (UNII: 5C5403N26O)  
    hydroxypropyl cellulose (70000 WAMW) (UNII: 66O7AQV0RT)  
    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:16837-298-12100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2009
    2NDC:16837-298-2525 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2009
    3NDC:16837-298-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2009
    4NDC:16837-298-652500 in 1 CARTON06/15/2020
    41 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:16837-298-674 in 1 CARTON06/15/2020
    51 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:16837-298-688 in 1 CARTON06/15/2020
    61 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02095803/01/2009
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)