Label: ACID REDUCER ORIGINAL STRENGTH- famotidine tablet, coated
- NDC Code(s): 42507-207-65, 42507-207-72
- Packager: HyVee Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated June 9, 2009
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- Active ingredient (in each tablet)
Famotidine 10 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
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
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:
- 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 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°-25°C (68°-77°F)
- protect from moisture and light
- Inactive ingredients
colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, indigo carmine aluminum lake FD&C blue no. 2, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 4000, pregelatinized corn starch, titanium dioxideClose
- Questions or comments?
- Principal Display Panel
Compare to Original Strength Pepcid® AC active ingredient
Famotidine Tablets, 10 mg
Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion
Acid Reducer Carton
- INGREDIENTS AND APPEARANCE
ACID REDUCER ORIGINAL STRENGTH
famotidine tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42507-207 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE 10 mg Product Characteristics Color PINK Score no score Shape ROUND Size 8mm Flavor Imprint Code 93;968 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42507-207-72 1 in 1 CARTON 1 60 in 1 BOTTLE 2 NDC:42507-207-65 3 in 1 CARTON 2 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075312 09/24/2001 Labeler - HyVee Inc (006925671)