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Maximum Strength Pepcid AC Tablets, Pepcid AC Gelcaps, Pepcid AC Tablets, Pepcid AC Chewable Tablets (J&J)




  • Description
  • Clinical Pharmacology
  • Warnings
  • Dosage and Administration
  • How Supplied



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  • DESCRIPTION

    (PEPCID AC)

    Each Pepcid AC Tablet, Chewable tablet, and gelcap contain famotidine 10 mg as an active ingredient.

    Each Maximum Strength Pepcid AC Tablet contains famotidine 20 mg as an active ingredient.

    Inactive Ingredients:

    TABLETS: Hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, starch, talc, titanium dioxide.

    CHEWABLE TABLETS:   aspartame, cellulose acetate, flavors, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, mannitol, microcrystalline cellulose, red ferric oxide.

    GELCAPS:   benzyl alcohol, black iron oxide, butylparaben, castor oil, edetate calcium disodium, FD&C red #40, gelatin, hypromellose, magnesium stearate, methylparaben, microcrystalline cellulose, pregelatinized corn starch, propylene glycol, propylparaben, sodium lauryl sulfate, sodium propionate, talc, titanium dioxide.

    Inactive Ingredients: (Max. Strength Pepcid AC.)

    carnauba wax, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide.

    Product Benefits:

    • 1 Tablet, Chewable Tablet or Gelcap relieves heartburn due to acid indigestion and sour stomach.
    • PEPCID AC prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.
    • It contains famotidine, a prescription-proven medicine.

    The ingredient in PEPCID AC and Maximum Strength Pepcid AC, famotidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in PEPCID AC and Maximum Strength Pepcid AC has been taken safely with many frequently prescribed medications.

    ACTION

    It is normal for the stomach to produce acid, especially after consuming food and beverages. However, acid in the wrong place (the esophagus), or too much acid, can cause burning pain and discomfort that interfere with everyday activities.

    ·Heartburn--Caused by acid in the esophagus

    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.

    Tips for Managing Heartburn:

    • Do not lie flat or bend over soon after eating.
    • Do not eat late at night, or just before bedtime.
    • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, and even some fruits and vegetables.
    • Eat slowly and do not eat big meals.
    • If you are overweight, lose weight.
    • If you smoke, quit smoking.
    • Raise the head of your bed.
    • Wear loose fitting clothing around your 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
    • if you have kidney disease, except under the advice and supervision of a doctor (for Maximum Strength Pepcid AC)

    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 shoulder; 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.

    DIRECTIONS

    Pepcid AC:

    • Adults and children 12 years and over:
    • Tablet & Gelcap: To relieve symptoms, swallow 1 tablet or gelcap with a glass of water. Do not chew.
    • Chewable Tablet: Do not swallow tablet whole: chew completely . To relieve symptoms, chew 1 tablet before swallowing.
    • Tablet & Gelcap: To prevent symptoms, swallow 1 tablet or gelcap with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn.
    • Chewable Tablet: To prevent symptoms, chew 1 chewable tablet before swallowing at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn.
    • Do not use more than 2 tablets, chewable tablets or gelcaps in 24 hours.
    • Children under 12 years: ask a doctor.

       Maximum Strength Pepcid AC:

    • 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 and package insert. They contain important information
    • store at 20°-30°C (68°-86°F)
    • protect from moisture

    in addition to the above the following also applies to the chewable tablet

    • phenylketonurics: Contains Phenylalanine 1.4 mg per chewable tablet

    HOW SUPPLIED

    Pepcid AC Tablet is available as a rose-colored tablet identified as `PEPCID AC'. NDC 16837-872

    Pepcid AC Gelcap is available as a rose and white gelatin coated, capsule shaped tablet identified as `PEPCID AC'. NDC 16837-856

    Pepcid AC Chewable Tablet is available as a rose-colored chewable tablet identified as `PEPCID AC'. NDC 16837-873

    Maximum Strength Pepcid AC Tablet is a white, "D" shaped, film coated tablet identifed as "PAC 20." NDC 16837 855













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    This page was last modified 30-JUN-07
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