Label: PEPCID AC- famotidine tablet, chewable
view more16837-854-35, 16837-854-50, 16837-854-65
- Packager: McNeil Consumer Pharmaceuticals Co.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated October 18, 2012
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
Famotidine 20 mgClose
- 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
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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
- adults and children 12 years and over:
- 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
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, sucraloseClose
- Questions or comments?
1-800-755-4008 (English) or 1-888-466-8746 (Spanish)Close
- PRINCIPAL DISPLAY PANEL
Famotidine Tablets 20 mg
Can take without water!
Just One Tablet!
Prevents & Relieves Heartburn
Due to Acid Indigestion
Berries 'n' Cream Flavor
- INGREDIENTS AND APPEARANCE
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)