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
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.
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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 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)