Label: ROLAIDS REGULAR STRENGTH MINT- calcium carbonate and magnesium hydroxide tablet, chewable
- NDC Code(s): 41167-1000-1, 41167-1000-2, 41167-1000-3, 41167-1000-5
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 29, 2022
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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- Warnings
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- Other information
- Inactive ingredients
- Active ingredient
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- Use
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Inactive ingredients
dextrose, flavor, magnesium stearate, silicon dioxide, stearic acid, sucralose, sucrose (309-053)
As a daily source of calcium and magnesium, chew 2 tablets twice daily.
Supplement Facts
Serving Size: 2 Tablets, Servings Per Container: 75, Amount Per Serving: Calories 7, Total Carb 1 g (<1% DV*), Sugars 1 g (†DV), Calcium 440 mg (44% DV), Magnesium 90 mg (23% DV). *Percent Daily Values (DV) are based on a 2,000 calories diet.
†Daily Value not established. - Other ingredients
- Active ingredient
- Purpose
- Use
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INGREDIENTS AND APPEARANCE
ROLAIDS REGULAR STRENGTH MINT
calcium carbonate and magnesium hydroxide tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-1000 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 550 mg MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 110 mg Inactive Ingredients Ingredient Name Strength DEXTROSE (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 16mm Flavor MINT Imprint Code R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-1000-1 3 in 1 CELLO PACK 09/01/2013 02/28/2022 1 NDC:41167-1000-5 12 in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:41167-1000-2 150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 02/28/2022 3 NDC:41167-1000-3 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 09/01/2013 Labeler - Chattem, Inc. (003336013)