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

  • NDC Code(s): 16837-246-05, 16837-246-08, 16837-246-25, 16837-246-26, view more
    16837-246-27, 16837-246-28, 16837-246-29, 16837-246-36, 16837-246-50, 16837-246-64
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 24, 2024

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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
    • contains FD&C yellow no. 5 (tartrazine) as a color additive
    • 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, corn syrup solids, crospovidone, dextrose excipient, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, flavors, gum arabic, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mineral oil, sucralose, triacetin

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 16837-246-25

    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

    Tropical Fruit Flavor

    actual size

    25

    Chewable Tablets

    pepcid-01

  • INGREDIENTS AND APPEARANCE
    PEPCID COMPLETE 
    famotidine, calcium carbonate, and magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:16837-246-055 in 1 CARTON01/01/200903/31/2013
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:16837-246-088 in 1 CARTON01/01/200903/31/2012
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:16837-246-2525 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2009
    4NDC:16837-246-2625 in 1 TRAY01/01/200904/11/2016
    41 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:16837-246-272500 in 1 TRAY01/01/200903/31/2014
    51 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:16837-246-282500 in 1 TRAY01/01/200903/31/2013
    61 in 1 POUCH; Type 0: Not a Combination Product
    7NDC:16837-246-2925 in 1 TRAY01/01/200905/31/2013
    71 in 1 POUCH; Type 0: Not a Combination Product
    8NDC:16837-246-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2009
    9NDC:16837-246-361 in 1 CARTON01/01/200901/24/2014
    935 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    10NDC:16837-246-6465 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/200903/24/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02095801/01/2009
    Labeler - Johnson & Johnson Consumer Inc. (878046358)
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