Other
Ultra Strength Rolaids Antacid, Assorted Fruit Chewable Tablets
Drug Facts
DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202
Rolaids Ultra Strength Antacid Tablet, Chewable
FDA Label NDC 69423-825
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 Antacid (NDC 69423-825). 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 other, active ingredient, purpose, uses, ask a doctor or pharmacist before use if you are, when using this product, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
(in each tablet)
Calcium carbonate USP 1000 mg
Magnesium hydroxide USP 200 mg
Purpose
Antacid
Antacid
Uses
for the relief of:
- heartburn
- sour stomach
- acid indigestion
- upset stomach associated with these symptoms
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
Directions
- chew 2-3 tablets as symptoms occur, or as directed by a doctor
Other Information
each tablet contains: calcium 400 mg, magnesium 85mg
- store at room temperature 20°-25°C (68°-77°F)
- contains FD&C yellow no.5 (tartrazine) as color additive
- contains FD & C yellow no.6
Inactive Ingredients
acacia, corn starch, corn syrup, dextrose, FD&C red no. 40 lake, FD&C yellow no. 5 lake, FD&C yellow no. 6 lake, fructose*, lactose, magnesium stearate, maltodextrin, medium chain triglycerides, natural and artificial flavor, propylene glycol alginate, silicon dioxide, stearic acid, sucralose, sucrose, tocopherols, triacetin
*May contain this ingredient
Questions?
1-833-372-2729
Tamper Evident
Do not use if inner foil seal is broken or missing.
Principal Display Panel
ULTRA STRENGTH
Rolaids
®ANTACID
GOES TO WORK INSTANTLY
Assorted Fruit
72 Chewable Tablets
* Please review the disclaimer below.
