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FIBER THERAPY

Major Pharmaceuticals

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

(in each 19g adult dose)

Methylcellulose (a non-allergenic fiber) 2g

Purpose

Bulk-forming fiber laxative

FIBER THERAPY 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.
  • 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

FIBER THERAPY

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

FIBER THERAPY

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)

FIBER THERAPY

FIBER THERAPY

methylcellulose POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5675
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
METHYLCELLULOSE (4000 MPA.S) 2 g

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C YELLOW NO. 6
POTASSIUM CITRATE
RIBOFLAVIN
SUCROSE
SILICON DIOXIDE
sorbitol
talc

Product Characteristics

Color
ORANGE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5675-16 454 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2008-04-18


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Be sure to consult your doctor before taking any medication!
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