famotidine, calcium carbonate and magnesium hydroxide

FDA Drug Profile — leader acid reducer complete, Dual Action Complete, DG Health acid reducer complete, ACID REDUCER COMPLETE, Acid Reducer Plus Antacid

Drug Details

Generic Name
famotidine, calcium carbonate and magnesium hydroxide
Brand Names
leader acid reducer complete, Dual Action Complete, DG Health acid reducer complete, ACID REDUCER COMPLETE, Acid Reducer Plus Antacid, complete dual action, injoy heartburn relief, CareOne Acid Reducer Complete, UP AND UP DUAL ACTION ACID REDUCER ANTACID, Equate Acid Reducer Complete, dual action complete, Signature Care Acid Reducer Complete, Good Sense Dual Action Complete, Basic Care Dual Action Complete, foster and thrive acid reducer antacid, topcare dual action complete, equaline complete dual action, Acid Reducer Complete
Application Number
ANDA077355
Sponsor
Cardinal Health 110, LLC. dba Leader
NDC Codes
22
Dosage Forms
TABLET, CHEWABLE
Routes
ORAL
Active Ingredients
CALCIUM CARBONATE, FAMOTIDINE, MAGNESIUM HYDROXIDE

Indications and Usage

Use relieves heartburn associated with acid indigestion and sour stomach

Warnings

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 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 • kidney disease Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids and acid reducers may interact with certain prescription drugs. 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. (1-800-222-1222)