Label: PEPCID AC- famotidine tablet, chewable

  • NDC Code(s): 16837-854-02, 16837-854-04, 16837-854-08, 16837-854-25, view more
    16837-854-35, 16837-854-50, 16837-854-65
  • Packager: McNeil Consumer Pharmaceuticals Co.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 10/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient (in each tablet)

    Famotidine 20 mg

    Close
  • Purpose

    Acid reducer

    Close
  • 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
    Close
  • 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.

    Close
  • Directions

    • adults and children 12 years and over:
      • do not swallow tablet whole: chew completely
      • to relieve symptoms, chew 1 tablet before swallowing
      • to prevent symptoms, chew 1 tablet before swallowing 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
    Close
  • 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
    Close
  • Inactive ingredients

    cellulose acetate, crospovidone, D&C red #7 calcium lake, dextrose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavors, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, sucralose

    Close
  • Questions or comments?

    1-800-755-4008 (English) or 1-888-466-8746 (Spanish)

    Close
  • PRINCIPAL DISPLAY PANEL

    MAXIMUM STRENGTH

    NDC 16837-854-25

    Pepcid® AC

    Famotidine Tablets 20 mg
    Acid Reducer

    EZ CHEWS
    Can take without water!

    Just One Tablet!

    Prevents & Relieves Heartburn
    Due to Acid Indigestion

    25
    Berries 'n' Cream Flavor
    Chewable Tablets

    PRINCIPAL DISPLAY PANEL
    Close
  • INGREDIENTS AND APPEARANCE
    PEPCID AC 
    famotidine tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:16837-854
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Famotidine (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8) Famotidine 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    cellulose acetate (UNII: 3J2P07GVB6)  
    crospovidone (UNII: 68401960MK)  
    dextrose (UNII: IY9XDZ35W2)  
    FD&C blue NO. 1 (UNII: H3R47K3TBD)  
    aluminum oxide (UNII: LMI26O6933)  
    FD&C red NO. 40 (UNII: WZB9127XOA)  
    hydroxypropyl cellulose (type E) (UNII: 66O7AQV0RT)  
    hypromelloses (UNII: 3NXW29V3WO)  
    lactose (UNII: J2B2A4N98G)  
    magnesium stearate (UNII: 70097M6I30)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color PURPLE Score no score
    Shape ROUND Size 12mm
    Flavor BERRY (Berries 'n' Cream) Imprint Code PAC;20
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16837-854-02 1 in 1 POUCH
    2 NDC:16837-854-08 8 in 1 CARTON
    2 NDC:16837-854-02 1 in 1 POUCH
    3 NDC:16837-854-04 2 in 1 PACKAGE
    3 NDC:16837-854-50 1 in 1 CARTON
    3 50 in 1 BOTTLE
    4 NDC:16837-854-25 1 in 1 CARTON
    4 25 in 1 BOTTLE
    5 NDC:16837-854-35 1 in 1 CARTON
    5 35 in 1 BOTTLE
    6 NDC:16837-854-65 1 in 1 CARTON
    6 65 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020801 02/01/2008
    Labeler - McNeil Consumer Pharmaceuticals Co. (160159638)
    Close