PREMIER VALUE- calcium polycarbophil tablet, film coated

Premier Value by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Fats

Active Ingredient (in each caplet)

Calcium polycarbophil 625 mg

equivalent to 500 mg polycarbophil

PURPOSE

PURPOSE

Bulk-forming laxative

USES

• ▪ relieves occasional constipation to help restore and maintain regularity
• ▪ this product generally produces bowel movement in 12 to 72 hours

WARNINGS

Choking Warning: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Ask a doctor before use if you have

• ▪ abdominal pain, nausea, or vomiting
• ▪ a sudden change in bowel habits that persists over a period of 2 weeks

Ask your doctor or pharmacist before use if you are

taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.

When using this product

• ▪ do not use for more than 7 days unless directed by a doctor
• ▪ do not take more than 8 tablets in a 24 hour period unless directed by a doctor

Stop use and ask a doctor if

rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

DIRECTIONS

• ▪ Take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. (See choking warning).
• ▪ This product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.

Age	Recommended	Daily maximum
adults & children 12 years of age and over	2 caplets once a day	up to 4 times a day
children under 12 years	consult a physician

OTHER INFORMATION

• each caplet contains: calcium 125 mg
• store at room temperature
• protect contents from moisture

Safety sealed: Do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENT

calcium carbonate, caramel color, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, , polyethylene glycol, silicon dioxide, sodium lauryl sulfate.

Questions or Comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

NDC# 68016-220-25

Premier Value®

COMPARE TO THE ACTIVE INGREDIENTS FIBERCON® CAPLETS*

Fiber Caplets

Calcium Polycarbophil 625 mg

Bulk-Forming

Fiber Laxative

• Gentle Relief of Constipation
• Won’t Cause Gas or Bloating
• Effective as Fiber Powders

250 CAPLETS

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

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by Pfizer Inc., owner of the registered trademark Fibercon® Caplets

INGREDIENTS AND APPEARANCE

PREMIER VALUE 
calcium polycarbophil tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-220
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W)	CALCIUM POLYCARBOPHIL	625 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARAMEL (UNII: T9D99G2B1R)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	BROWN	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	RP120
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-220-25	250 in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/16/2019

Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)