GNP FIBER THERAPY- methylcellulose tablet

GNP Fiber Therapy by

Drug Labeling and Warnings

GNP Fiber Therapy by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Methylcellulose 500 mg

Purpose

Bulk-forming laxative

Uses

• helps restore and maintain regularity and relieves constipation (irregularity)
• in the treatment of constipation associated with other bowel disorders when recommended by a doctor

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

• abdominal pain, nausea or vomiting
• a sudden change in bowel habits that persists over a period of 2 weeks
• sensitivity to any of the ingredients

When using this product

• do not exceed recommended maximum dose unless directed by a doctor
• do not use laxative products for a period longer than one week unless directed by a doctor

Stop use and ask a doctor if

• rectal bleeding occurs
• you fail to have a bowel movement after use

Keep out of reach of children

In case of overdose, get medical help or contact a poison control center right away.

Directions

This product generally produces effect in 12-72 hours

take this product (child or adult) dose with atleast 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 and children over 12 years	2 caplets	up to 6 times daily
children (6 to 12 years)	1 caplet	up to 6 times daily
children under 6 years	ask a doctor	ask a doctor

Other information

• each caplet contains: sodium 10 mg
• store at room temperature 15o-30oC (59o-86oF)
• protect contents from moisture
• keep tightly closed
• tamper evident: Do not use if printed seal under cap is torn or missing

Inactive ingredients

citric acid, colloidal silicon dioxide, crospovidone, FD&C yellow 6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulphate

Principal Display Panel

Good Neighbor Pharmacy

compare to Citrucel caplets active ingredient

fiber therapy

Methylcellulose Fiber Laxativebulk-forming laxative

easy to take with you

gentle fiber for regularity

daily source of 100% soluble fiber

100 caplets

INGREDIENTS AND APPEARANCE

GNP FIBER THERAPY 
methylcellulose tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24385-466
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 68401960MK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	G188
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24385-466-78	1 in 1 CARTON	09/09/2011
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/09/2011

Labeler - Amerisource Bergen (007914906)

Registrant - Guardian Drug Company (119210276)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	manufacture(24385-466)