PV EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUIT- calcium carbonate tablet, chewable

PV Extra Strength Smooth by

Drug Labeling and Warnings

PV Extra Strength Smooth by is a Otc medication manufactured, distributed, or labeled by PHARMACY VALUE ALLIANCE, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (per tablet)

Calcium Carbonate USP 750 mg

Purpose

Antacid

Uses

relieves:

• Heartburn
• acid indigestion
• sour stomach
• upset stomach associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if you are

• presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

• do not take more than 10 tablets in a 24-hour period
• 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 as symptoms occur, or as directed by a doctor.
• do not take for symptoms that persists for more than 2 weeks unless advised by a doctor

Other information

• each tablet contains: calcium 300 mg
• store at room temperature. keep the container tightly closed.

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

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.

Questions or comments?

1-866-467-2748

Principal Display Panel

Premier Value®

NDC: 68016-697-60

*Compare to active ingredient Extra Strength Tums® Smoothies™

EXTRA STRENGTH

Smooth Antacid

CALCIUM CARBONATE USP 750 mg
Assorted Fruit

Naturally and Artificially Flavored

Fast Relief of Upset Stomach, Heartburn and Acid Indigestion

60 Chewable Tablets

GLUTEN-FREE

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

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

INGREDIENTS AND APPEARANCE

PV EXTRA STRENGTH SMOOTH  ANTACID ASSORTED FRUIT
calcium carbonate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-697
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, GREEN, 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: 68016-697-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	01/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part331	01/28/2020

Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)