FIBER THERAPY- methylcellulose powder, for solution

FIBER THERAPY by

Drug Labeling and Warnings

FIBER THERAPY by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

(in each 19g adult dose)

Methylcellulose (a non-allergenic fiber) 2g

Purpose

Bulk-forming fiber laxative

Uses

• relieves constipation (irregularity)
• helps to restore and maintain regularity
• for constipation associated with other bowel disorders like IBS when recommended by a doctor
• 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 for two weeks
• abdominal pain, nausea or vomiting
• sensitivity to any of the ingredients

Stop use and ask a doctor if

• constipation lasts more than 7 days
• you fail to have a bowl movement after use
• 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.

When using this product

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

Directions

• MIX 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
• use product at the first sign of constipation or irregularity
• put one dose in a full glass of cold water
• stir briskly and drink promptly
• drinking another glass of water is helpful

FIBER THERAPY Orange Flavor 

• Age:

  Dose

• adults & children above 12 years of age:

  start with 1 heaping tablespoon (19g). Increase as needed, 1 heaping tablespoon at a time, up to 3 times per day.

• children 6 - 12 years of age:

  half the adult dose in 8 ounces of cold water once daily.

Other information

• Each adult dose contains approximately:
• sodium 3mg
• potassium 105mg
• contributes 60 calories from sucrose and sorbitol
• store below 86°F (30°C)
• protect contents from humidity
• keep tightly closed

    Tamper Evident: Do not use if printed seal under cap is torn or missing

Inactive ingredients

citric acid, FD&C yellow #6 lake, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin, silicondioxide, sorbitol, sucrose, talc.

Questions or comments?

call toll-free 1-800-616-2471

*This product is not manufactured or distributed by GlaxoSmithKline the distributor of Citrucel®

Distributed by:

MAJOR PHARMACEUTICALS

Livonia, MI 48150  USA

DIRECTIONS FOR USE

1. Fill glass with at least 8 oz. of cold water.

2. Add the adult or child dose listed in the directions. 3. Stir briskly until dissolved and drink promptly. Drinking an additional glass of water is helpful.

TAMPER EVIDENT PACKAGE

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

Principal Display Panel

NDC: 0904-5675-16

FIBER THERAPY

METHYLCELLULOSE FOR REGULARITY

Orange FLAVOR

NET WT 16 OZ (454 GRAMS)

INGREDIENTS AND APPEARANCE

FIBER THERAPY 
methylcellulose powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-5675
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)	2 g  in 19 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
RIBOFLAVIN (UNII: TLM2976OFR)
SUCROSE (UNII: C151H8M554)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-5675-16	454 g in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/18/2008

Labeler - Major Pharmaceuticals (191427277)