PREMIER VALUE FIBER THERAPY- methylcellulose tablet

Premier Value Fiber Therapy by

Drug Labeling and Warnings

Premier Value Fiber Therapy 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 (in each caplet)

Methylcellulose 500mg

Purpose

Bulk-forming fiber laxative (a non-allergenic fiber)

Uses

• ▪ relieves occasional constipation (irregularity)
• ▪ generally produces a bowel movement in 12 -72 hours.

Warnings

Choking: 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

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

Stop use and ask a doctor if

• ▪ Constipation lasts more than 7 days
• ▪ you have rectal bleeding
• ▪ 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 this product (child or adult dose) 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.

Age	Dose	Maximum Dose
adults & children 12 years of age and over	start with 2 caplets. Increase as needed up to 6 times per day.	Do not exceed 12 caplets per day
Children 6-11 years of age	Start with 1 caplet. Increase as needed up to 6 times per day	Do not exceed 6 caplets per day
children under 6 years of age	Consult a physician	Consult a physician

Other information

• each caplet contains: calcium 18 mg
• store at room temperature
• protect contents from humidity
• keep tightly closed

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

Inactive ingredients

adipic acid, calcium carbonate, crospovidone, FD&C yellow no. 6, magnesium stearate, microcrystalline cellulose, polysorbate 80, silica.

Do not use if printed seal under cap is torn or missing.

Questions or comments?

1-866-467-2748

Principal Display Panel

Premier Value®

NDC# 68016-122-10

*COMPARE TO THE ACTIVE INGREDIENTS CITRUCEL® CAPLETS

Fiber Therapy

Fiber Therapy for Regularity

Methylcellulose

• Gentle and clinically proven effective
• Gives you additional fiber to help relieves occasional constipation
• Fiber for irregularity that won’t cause excess gas**
•   100 CAPLETS

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

*When Used As Directed.

**Based on Laboratory Testing.

Individual Results May Vary.

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark CITRUCEL® Caplets.

INGREDIENTS AND APPEARANCE

PREMIER VALUE FIBER THERAPY 
methylcellulose tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-122
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 MPA.S) - UNII:MRJ667KA5E)	METHYLCELLULOSE (4000 MPA.S)	500 mg

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID (UNII: 76A0JE0FKJ)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	ORANGE (Light orange)	Score	no score
Shape	CAPSULE (Caplet)	Size	19mm
Flavor		Imprint Code	RP122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-122-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/19/2019

Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)