Label: PEPCID AC- famotidine tablet, chewable 

  • Label RSS
  • 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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 LABEL Item Code (Source) NDC:16837-854
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Famotidine (Famotidine) Famotidine 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    cellulose acetate  
    crospovidone  
    dextrose  
    FD&C blue NO. 1  
    aluminum oxide  
    FD&C red NO. 40  
    hydroxypropyl cellulose (type E)  
    hypromelloses  
    lactose  
    magnesium stearate  
    sucralose  
    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