Label: PEPCID AC ORIGINAL STRENGTH- famotidine tablet, film coated

  • NDC Code(s): 16837-872-10, 16837-872-20, 16837-872-22, 16837-872-30, view more
    16837-872-31, 16837-872-60, 16837-872-75, 16837-872-90
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Famotidine 10 mg

  • Purpose

    Acid reducer

  • Uses

    • relieves heartburn associated with acid indigestion and sour stomach
    • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
  • 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. 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:
      • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
      • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn
      • do not use more than 2 tablets in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    • 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
  • Inactive ingredients

    carnauba wax, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 16837-872-20

    ORIGINAL STRENGTH

    Pepcid ®

    AC

    Famotidine Tablets 10 mg

    Acid Reducer

    Just One Tablet!

    Prevents & Relieves Heartburn

    Due to Acid Indigestion

    actual size

    30 Tablets

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    PEPCID AC  ORIGINAL STRENGTH
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16837-872
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorpink (pale rose) Scoreno score
    ShapeSQUARE (rounded edges) Size7mm
    FlavorImprint Code PEPCID;AC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16837-872-101 in 1 CARTON01/21/201112/31/2023
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:16837-872-303 in 1 CARTON10/01/1995
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:16837-872-314 in 1 CARTON10/01/199512/31/2023
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:16837-872-601 in 1 CARTON10/01/1995
    460 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:16837-872-901 in 1 CARTON10/01/1995
    590 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:16837-872-203 in 1 CARTON01/21/2011
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:16837-872-221 in 1 CARTON01/21/2011
    790 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    8NDC:16837-872-751 in 1 CARTON03/15/202108/31/2024
    875 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02032510/01/1995
    Labeler - Kenvue Brands LLC (118772437)
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