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

  • NDC Code(s): 16837-855-05, 16837-855-09, 16837-855-12, 16837-855-13, view more
    16837-855-14, 16837-855-15, 16837-855-16, 16837-855-17, 16837-855-18, 16837-855-19, 16837-855-20, 16837-855-25, 16837-855-40, 16837-855-49, 16837-855-50, 16837-855-51, 16837-855-52, 16837-855-65, 16837-855-67, 16837-855-70, 16837-855-75, 16837-855-80, 16837-855-85
  • 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 (in each tablet)

    Famotidine 20 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.
    • if you have kidney disease, except under the advice and supervision of a 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

    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 10 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, talc, titanium dioxide

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 16837-855-14

    MAXIMUM STRENGTH

    Pepcid®
    AC

    Famotidine Tablets 20 mg
    Acid Reducer

    Just One Tablet!
    Prevents & Relieves Heartburn
    Due to Acid Indigestion

    actual size

    25 Tablets

    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    PEPCID AC   MAXIMUM STRENGTH
    famotidine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16837-855
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Famotidine (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8) Famotidine20 mg
    Inactive Ingredients
    Ingredient NameStrength
    carnauba wax (UNII: R12CBM0EIZ)  
    HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeSEMI-CIRCLE (D shaped) Size9mm
    FlavorImprint Code PAC;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16837-855-051 in 1 CARTON09/01/2003
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:16837-855-255 in 1 CARTON09/01/200303/31/2014
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:16837-855-491 in 1 CARTON09/01/2003
    350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:16837-855-501 in 1 CARTON09/01/2003
    450 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:16837-855-5250 in 1 TRAY09/01/2003
    51 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:16837-855-651 in 1 CARTON09/01/2003
    665 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:16837-855-671 in 1 CARTON09/01/2003
    765 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    8NDC:16837-855-701 in 1 CARTON09/01/2003
    870 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    9NDC:16837-855-751 in 1 CARTON09/01/2003
    975 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    10NDC:16837-855-801 in 1 CARTON09/01/2003
    1080 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    11NDC:16837-855-851 in 1 CARTON09/01/2003
    1185 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    12NDC:16837-855-091 in 1 PACKAGE09/01/2003
    12100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    13NDC:16837-855-121 in 1 CARTON09/01/2003
    13100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    14NDC:16837-855-131 in 1 POUCH; Type 0: Not a Combination Product09/01/2003
    15NDC:16837-855-145 in 1 CARTON09/01/2003
    155 in 1 BLISTER PACK; Type 0: Not a Combination Product
    16NDC:16837-855-151 in 1 CARTON09/01/2003
    1635 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    17NDC:16837-855-171 in 1 CARTON09/01/2003
    1765 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    18NDC:16837-855-181 in 1 CARTON09/01/2003
    18100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    19NDC:16837-855-405 in 1 CARTON09/01/2003
    198 in 1 BLISTER PACK; Type 0: Not a Combination Product
    20NDC:16837-855-5112 in 1 CARTON09/01/2003
    205 in 1 BLISTER PACK; Type 0: Not a Combination Product
    21NDC:16837-855-161 in 1 CARTON09/01/2003
    2150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    22NDC:16837-855-202 in 1 PACKAGE08/22/2014
    22NDC:16837-855-161 in 1 CARTON
    2250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    23NDC:16837-855-191 in 1 CARTON04/27/2015
    238 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02032509/01/2003
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)