EXTRA STRENGTH SMOOTH- antacid tablets tablet, chewable

Extra Strength Smooth by

Drug Labeling and Warnings

Extra Strength Smooth by is a Otc medication manufactured, distributed, or labeled by CVS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Calcium Carbonate USP 750mg

Purpose

Antacid

Uses

relieves:

heartburn

sour stomach

acid indigestion

upset stomach associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

do not take more than 10 tablets in 24 hours

if pregnant do not take more than 6 tablets in 24 hours

do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Keep out of Reach of Children

Directions

adults and children 12 years of age and over: chew 2-4 tablets completely as symptoms occur, or as directed by a doctor. Do not swallow tablets whole.

do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.

Other Information

each tablet contains: calcium 300mg

Store at room temperature. Keep the container tightly closed

Inactive ingredients

adipic acid, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Red No. 40 Lake, FD&C Yellow No. 6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose

Safety sealed: Do not use if printed seal under cap is torn or missing

Questions or comments?

1-866-467-2748

Package/Label Principal Display Panel

*Compare to the active ingredient in Extra Strength Tums® Smoothies™

EXTRA STRENGTH

Smooth Antacid Tablets

Calcium Carbonate 750 mg

For Fast Relief of Heartburn, Acid Indigestion & Upset Stomach

Assorted Fruit

Naturally and Artificially Flavored

60 Chewable Tablets

Distributed by:

*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark, Extra Strength Tums® Smoothies™

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH SMOOTH 
antacid tablets tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-115
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	750 mg

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID (UNII: 76A0JE0FKJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PINK (dark pink) , ORANGE, YELLOW	Score	no score
Shape	ROUND	Size	19mm
Flavor	FRUIT (Assorted)	Imprint Code	RP115
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-115-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/06/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	08/06/2021

Labeler - CVS (062312574)