PREMIER VALUE MAXIMUM STRENGTH ASSORTED FRUIT- calcium carbonate, simethicone tablet, chewable

Premier Value Maximum Strength by

Drug Labeling and Warnings

Premier Value Maximum Strength by is a Otc medication manufactured, distributed, or labeled by PHARMACY VALUE ALLIANCE, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each tablet)

Calcium carbonate 1000 mg

Simethicone 60 mg

Purpose

Antacid

Antigas

Uses

relieves:

• ▪ acid indigestion
• ▪ heartburn
• ▪ sour stomach
• ▪ upset stomach due to these symptoms
• ▪ bloating and pressure commonly referred to as gas

Warnings

Do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Ask a doctor before use if you have

• ▪ kidney stones
• ▪ a calcium-restricted diet

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

at maximum dose, constipation may occur.

Stop use and ask a doctor if

symptoms persist for more than 2 weeks.

Keep out of reach of children.

Directions

• ▪ adults and children 12 years and older: chew 1 to 2 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablets whole.
• ▪ do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Other information

• ▪ each tablet contains: calcium 400 mg
• ▪ store at room temperature
• ▪ keep tightly closed and dry
• ▪ avoid freezing
• ▪ do not use if printed inner seal is broken or missing

Inactive ingredients

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

Questions or comments?

1-866-467-2748

Package/Label Principal Display Panel

Premier Value®

*COMPARE TO THE ACTIVE INGREDIENTS IN MAALOX® ADVANCED MAXIMUM STRENGTH

NDC: 68016-249-00

Antacid & Anti-Gas

MAXIMUM STRENGTH

Fast relief of:

• ▪ Heartburn
• ▪ Acid indigestion
• ▪ Pressure & bloating
•   Assorted Fruit
•   Naturally Artificially Flavored

90 Chewable Tablets

INDEPENDENTLY TESTED PV SATISFACTION GURANTEED

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., the distributor of Maalox® Advanced Maximum Strength.

INGREDIENTS AND APPEARANCE

PREMIER VALUE MAXIMUM STRENGTH  ASSORTED FRUIT
calcium carbonate, simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-249
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)	CALCIUM CARBONATE	1000 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	60 mg

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID (UNII: 76A0JE0FKJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	ORANGE, YELLOW, RED (PINKISH)	Score	no score
Shape	ROUND	Size	17mm
Flavor	FRUIT (ASSORTED)	Imprint Code	RP104
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-249-00	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	04/22/2019

Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)