Calcium carbonate and Magnesium hydroxide

FDA Drug Profile — Rolaids Extra Strength Mint, Rolaids Extra Strength Fruit, Rolaids Ultra Strength Antacid Strawberry, Rolaids Ultra Strength Mint, Rolaids ORIGINAL

Drug Details

Generic Name
Calcium carbonate and Magnesium hydroxide
Brand Names
Rolaids Extra Strength Mint, Rolaids Extra Strength Fruit, Rolaids Ultra Strength Antacid Strawberry, Rolaids Ultra Strength Mint, Rolaids ORIGINAL, Rolaids Extra Strength Antacid Mint
Application Number
M001
Sponsor
Chattem, Inc.
NDC Codes
6
Dosage Forms
TABLET, CHEWABLE
Routes
ORAL
Active Ingredients
CALCIUM CARBONATE, 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)