Drug Facts
Rolaids ULTRA STRENGTH 1200
Rolaids Ultra Strength 1200 Tablet, Chewable
FDA Label NDC 84126-322
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Rolaids Ultra Strength 1200 (NDC 84126-322). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
(in each chewable tablet)
Calcium carbonate 1000 mg
Magnesium hydroxide 200 mg
Purpose
Antacid
Antacid
Uses
for the relief of:
- heartburn
- acid indigestion
- sour stomach
- upset stomach associated with these symptoms
Ask A Doctor Before Use If You Have
- kidney disease
- a magnesium-retricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
- now taking a prescription drug. Antacids may interact with certain prescription drugs.
When Using This Product
- do not take more than 7 tablets in a 24-hour period
- do not use the maximum dosage for more than 2 weeks, except under the advice and supervision of a doctor.
Directions
- adults and children 12 years and over: 2-3 chewable tablets as symptoms occur, or as directed by a doctor.
Other Information
- each chewable tablet contains:
- calcium 400 mg
- magnesium 90 mg
- contains FD&C Yellow No. 5 (tartrazine) as color additive
- store at room temperature 20° -25°C (68° -77°F)
Inactive Ingredients
anhydrous citric acid, carboxymethylcellulose sodium, corn starch, dextrose, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 5 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, flavors, magnesium stearate, malic acid, maltodextrin, silicon dioxide, sodium sulfate, sucrose, water, xanthan gum, xylitol
Questions?
1-833-372-2729
Tamper Evident:
DO NOT USE IF SEAL UNDER CAP IS MISSING OR DAMAGED.
Other
DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202
Principal Display Panel
CALCIUM CARBONATE, MAGNESIUM HYDROXIDE • ANTACID
Rolaids
ULTRA STRENGTH
1200*
STRONG • FAST
HEARTBURN
RELIEF
*1200 mg Antacid per tablet
ASSORTED FRUIT FLAVOR
72 CHEWABLE TABLETS
322 (322)
* Please review the disclaimer below.
