ROLAIDS ULTRA STRENGTH ANTACID ASSORTED FRUIT- calcium carbonate, magnesium hydroxide tablet, chewable

Rolaids Ultra Strength Antacid by

Drug Labeling and Warnings

Rolaids Ultra Strength Antacid by is a Otc medication manufactured, distributed, or labeled by THE PROCTER & GAMBLE MANUFACTURING COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Ultra Strength Rolaids Antacid, Assorted Fruit Chewable Tablets

Drug Facts

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

Warnings

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

Keep out of reach of children.

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.

SPL UNCLASSIFIED SECTION

DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL

ULTRA STRENGTH
Rolaids ®ANTACID

GOES TO WORK INSTANTLY
Assorted Fruit
72 Chewable Tablets

INGREDIENTS AND APPEARANCE

ROLAIDS ULTRA STRENGTH ANTACID  ASSORTED FRUIT
calcium carbonate, magnesium hydroxide tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-825
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	1000 mg
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM HYDROXIDE	200 mg

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ACACIA (UNII: 5C5403N26O)
STARCH, CORN (UNII: O8232NY3SJ)
CORN SYRUP (UNII: 9G5L16BK6N)
FRUCTOSE (UNII: 6YSS42VSEV)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPYLENE GLYCOL ALGINATE (UNII: 26CD3J2R0C)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIACETIN (UNII: XHX3C3X673)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	red, yellow, orange	Score	no score
Shape	ROUND	Size	19mm
Flavor	FRUIT (cherry, lemon, orange)	Imprint Code	R;U
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-825-10	10 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2024
2	NDC: 69423-825-72	72 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	01/01/2024

Labeler - THE PROCTER & GAMBLE MANUFACTURING COMPANY (004238200)