Major Fiber Therapy Orange Flavor

Major Fiber Therapy Orange Flavor
SPL v5
SPL
SPL Set ID 31033385-7932-448e-8980-11f2e8197eae
Route
ORAL
Published
Effective Date 2025-05-12
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 Maltodextrin Potassium Citrate Silicon Dioxide Sucrose

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-08-09

Description

Methylcellulose 2g (a non-allergenic fiber)

Purpose

Bulk-forming fiber laxative


Medication Information

Purpose

Bulk-forming fiber laxative

Description

Methylcellulose 2g (a non-allergenic fiber)

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
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.

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

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

children under 6 years of age

ask a doctor

Other Information
  • each adult dose contains approximately
  • 3 mg of sodium
  • 105 mg 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,

Questions Or Comments?

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

Relabeled By: Preferred Pharmaceuticals Inc.

Livonia, MI 48152, USA

Relabeled By: Preferred Pharmaceuticals Inc.

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.

Principal Display Panel

NDC 68788-7995-4

Compare to the Active Ingredient in CITRUCEL®*

FIBER THERAPY

Methylcellulose

Easy to Mix No Gritty Texture

100% Soluble Fiber for Controlled Regularity

ORANGE FLAVOR

NET WT 16 OZ (454 GRAMS)

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
Active Ingredient (in Each 19g Adult Dose/ Rounded Tablespoon)

Methylcellulose 2g (a non-allergenic fiber)


Structured Label Content

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

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.

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

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

children under 6 years of age

ask a doctor

Other Information (Other information)
  • each adult dose contains approximately
  • 3 mg of sodium
  • 105 mg 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,

Questions Or Comments? (Questions or comments?)

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

Relabeled By: Preferred Pharmaceuticals Inc.

Livonia, MI 48152, USA

Relabeled By: Preferred Pharmaceuticals Inc.

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.

Principal Display Panel

NDC 68788-7995-4

Compare to the Active Ingredient in CITRUCEL®*

FIBER THERAPY

Methylcellulose

Easy to Mix No Gritty Texture

100% Soluble Fiber for Controlled Regularity

ORANGE FLAVOR

NET WT 16 OZ (454 GRAMS)

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
Active Ingredient (in Each 19g Adult Dose/ Rounded Tablespoon) (Active ingredient (in each 19g adult dose/ rounded tablespoon))

Methylcellulose 2g (a non-allergenic fiber)


Advanced Ingredient Data


Raw Label Data

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