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., McNeil Consumer Healthcare Division
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 22, 2019

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

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids 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 seal under bottle cap printed "SAFETY SEAL®" is open or torn
  • 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–Acid reducer
    Calcium carbonate–Antacid
    Magnesium hydroxide–Antacid

    Just One Tablet!
    Relieves Heartburn Due to Acid Indigestion

    actual size

    25
    Chewable Tablets
    Tropical Fruit Flavor

    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:16837-246
    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
    cellulose acetate (UNII: 3J2P07GVB6)  
    starch, corn (UNII: O8232NY3SJ)  
    corn syrup (UNII: 9G5L16BK6N)  
    crospovidone (15 mpa.s at 5%) (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 (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)  
    triacetin (UNII: XHX3C3X673)  
    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., McNeil Consumer Healthcare Division (878046358)