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
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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- 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?
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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 LABEL Item Code (Source) NDC:42507-207 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FAMOTIDINE (FAMOTIDINE) 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)