drug facts

drug facts
SPL v10
SPL
SPL Set ID 5dddab8d-0041-4486-9ed9-1dbd13575b47
Route
oral
Published
Effective Date 2025-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
methylcellulose (4000 mpa.s) (2 g)
Inactive Ingredients
citric acid monohydrate fd&c yellow no. 6 potassium citrate riboflavin sucrose silicon dioxide sorbitol talc

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
otc monograph drug active Since 2008-04-18

Purpose

Bulk-forming fiber laxative

Description

(in each 19g adult dose/ rounded tablespoon) Methylcellulose 2g (a non-allergenic fiber)


Medication Information

Recent Major Changes

TAMPER EVIDENT PACKAGE

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

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.

Uses
  • relieves constipation (irregularity)
  • helps to restore and maintain regularity
  • for treating bowel disorders when recommended by a doctor
  • generally provide effect in 12-72 hours
Purpose

Bulk-forming fiber laxative

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

  Age

  Dose

 adults & children above 12 years of age and over

 One rounded tablespoon. (19 g) in 8 ounces of water fluid up to 3 times daily at the first sign of constipation or irregularity

 children 6 - 12 years of age

Children under 6 years of age

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

ask a doctor

Other Information
  • Each adult dose contains approximately
  • 3mg of sodium
  • 105mg potassium
  • contributes 60 calories from sucrose and sorbitol
  • store at room temperature
  • 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 aluminum lake, maltodextrin, flavor (natural and artificial), potassium citrate, , silica, sucrose,

Description

(in each 19g adult dose/ rounded tablespoon) Methylcellulose 2g (a non-allergenic fiber)

Principal Display Panel

NDC 0904-5675-16

FIBER THERAPY

Methylcellulose

Easy to Mix

No Gritty Texture

100% Soluble Fiber for Controlled Regularity

ORANGE FLAVOR

NET WT 16 OZ (454 GRAMS)

Active Ingredient

(in each 19g adult dose/ rounded tablespoon)

Methylcellulose 2g (a non-allergenic fiber)

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

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152, USA

DIRECTIONS FOR USE

1. Fill glass with at least 8 ounces 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.

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 
Stop Use and Ask A Doctor If
  • you have rectal bleeding
  • you fail to have a bowl movement after use.
  • 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.

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

Structured Label Content

Recent Major Changes (34066-1)

TAMPER EVIDENT PACKAGE

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

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.

Uses
  • relieves constipation (irregularity)
  • helps to restore and maintain regularity
  • for treating bowel disorders when recommended by a doctor
  • generally provide effect in 12-72 hours
Purpose

Bulk-forming fiber laxative

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

  Age

  Dose

 adults & children above 12 years of age and over

 One rounded tablespoon. (19 g) in 8 ounces of water fluid up to 3 times daily at the first sign of constipation or irregularity

 children 6 - 12 years of age

Children under 6 years of age

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

ask a doctor

Other Information (Other information)
  • Each adult dose contains approximately
  • 3mg of sodium
  • 105mg potassium
  • contributes 60 calories from sucrose and sorbitol
  • store at room temperature
  • protect contents from humidity
  • keep tightly closed

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

Inactive Ingredients (Inactive ingredients)

citric acid, FD&C yellow 6 aluminum lake, maltodextrin, flavor (natural and artificial), potassium citrate, , silica, sucrose,

Principal Display Panel

NDC 0904-5675-16

FIBER THERAPY

Methylcellulose

Easy to Mix

No Gritty Texture

100% Soluble Fiber for Controlled Regularity

ORANGE FLAVOR

NET WT 16 OZ (454 GRAMS)

Active Ingredient (Active ingredient)

(in each 19g adult dose/ rounded tablespoon)

Methylcellulose 2g (a non-allergenic fiber)

Questions Or Comments? (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

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152, USA

DIRECTIONS FOR USE

1. Fill glass with at least 8 ounces 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.

When Using This Product (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 
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding
  • you fail to have a bowl movement after use.
  • These could be signs of a serious condition.
Keep Out of Reach of Children. (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.

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)