Drug Facts

Drug Facts
SPL v16
SPL
SPL Set ID 9d5f2244-a610-4d45-b6e8-e79bb17a558f
Route
ORAL
Published
Effective Date 2024-06-10
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 Anhydrous Dibasic Calcium Phosphate Fd&c Yellow No. 6 Maltodextrin Potassium Citrate Riboflavin Sucrose Titanium Dioxide Tricalcium Phosphate Aspartame Malic Acid

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-09-16

Description

Methylcellulose (a non-allergenic fiber) 2 g

Purpose

Bulk-forming fiber laxative


Medication Information

Purpose

Bulk-forming fiber laxative

Description

Methylcellulose (a non-allergenic fiber) 2 g

Uses
  • relieves occasional constipation (irregularity)
  • 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.

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

CITRUCEL Orange

Age

Dose

adults and children 12 years of age and over

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

children 6 - 11 years of age

start with 2.5 level teaspoons . Increase as needed, 2.5 level teaspoons at a time, up to 3 times per day.

children under 6 years of age

consult a doctor

CITRUCEL Sugar Free

Age

Dose

adults and children 12 years of age and over

start with 1 rounded tablespoon . Increase as needed, 1 rounded tablespoon at a time, up to 3 times per day.

children 6 - 11 years of age

start with 2 level teaspoons . Increase as needed, 2 level teaspoons at a time, up to 3 times per day.

children under 6 years of age

consult a doctor

Principal Display Panel

HALEON

Great Taste

CITRUCEL

METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY

  • Gentle and clinically proven effective*
  • Gives you additional fiber to help relieve occasional constipation
  • Fiber for irregularity that won’t cause excess gas**

orangeFLAVOR

NET WT 30 OZ (850 g)

Great Tasting

CITRUCEL Orange

Citrucel offers these great benefits:

  • Gentle and clinically proven effectiveto help relieve occasional constipation*
  • Fiber that won't fermentto cause excess gas **
  • 100% Soluble, gluten-free, non-allergenic fiber
  • *When Used As Directed.
  • **Based On Laboratory Testing. Individual Results May Vary.

TAMPER EVIDENT PACKAGE

DO NOT USE IF FOIL SEAL IS MISSING OR BROKEN.

211407

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • a sudden change in bowel habits that persists for two weeks
  • abdominal pain, nausea, or vomiting
Other Information (citrucel Orange)
  • each heaping tablespoon contains:calcium 80 mg, potassium 105 mg, sodium 10 mg
  • each heaping tablespoon contributes 60 calories from sucrose and maltodextrin
  • store below 25°C (77°F)
  • protect contents from humidity
  • keep tightly closed
Inactive Ingredients (citrucel Orange)

citric acid, dibasic calcium phosphate, FD&C yellow #6 lake, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin, soy lecithin, sucrose, titanium dioxide, tricalcium phosphate

Other Information (citrucel Sugar Free)
  • each rounded tablespoon contains:calcium 80 mg, potassium 120 mg, sodium 15 mg
  • each rounded tablespoon contributes 30 calories from maltodextrin
  • store below 25°C (77ºF)
  • protect contents from humidity
  • keep tightly closed
  • Phenylketonurics: CONTAINS PHENYLALANINE 48.6 mg per adult dose
Questions Or Comments? (citrucel Orange)

1-800-897-6081

Great Tasting

CITRUCEL Orange

DIRECTIONS FOR USE (NO SCOOP DOSING):

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

2. Measure heaping tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly.

Inactive Ingredients (citrucel Sugar Free)

aspartame, dibasic calcium phosphate, FD&C yellow #6 lake, malic acid, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin

Questions Or Comments? (citrucel Sugar Free)

1-800-897-6081

DIRECTIONS FOR USE (NO SCOOP DOSING):

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

2. Measure rounded tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly.

Stop Use and Ask A Doctor If (citrucel Orange)
  • constipation lasts more than 7 days
  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • These could be signs of a serious condition.
Stop Use and Ask A Doctor If (citrucel Sugar Free)
  • constipation lasts more than 7 days
  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • These could be signs of a serious condition.
Active Ingredient (in Each Heaping Tablespoon) Citrucel Orange

Methylcellulose (a non-allergenic fiber) 2 g

Active Ingredient (in Each Rounded Tablespoon) Citrucel Sugar Free

Methylcellulose (a non-allergenic fiber) 2 g


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement 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

CITRUCEL Orange

Age

Dose

adults and children 12 years of age and over

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

children 6 - 11 years of age

start with 2.5 level teaspoons . Increase as needed, 2.5 level teaspoons at a time, up to 3 times per day.

children under 6 years of age

consult a doctor

CITRUCEL Sugar Free

Age

Dose

adults and children 12 years of age and over

start with 1 rounded tablespoon . Increase as needed, 1 rounded tablespoon at a time, up to 3 times per day.

children 6 - 11 years of age

start with 2 level teaspoons . Increase as needed, 2 level teaspoons at a time, up to 3 times per day.

children under 6 years of age

consult a doctor

Principal Display Panel

HALEON

Great Taste

CITRUCEL

METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY

  • Gentle and clinically proven effective*
  • Gives you additional fiber to help relieve occasional constipation
  • Fiber for irregularity that won’t cause excess gas**

orangeFLAVOR

NET WT 30 OZ (850 g)

Great Tasting

CITRUCEL Orange

Citrucel offers these great benefits:

  • Gentle and clinically proven effectiveto help relieve occasional constipation*
  • Fiber that won't fermentto cause excess gas **
  • 100% Soluble, gluten-free, non-allergenic fiber
  • *When Used As Directed.
  • **Based On Laboratory Testing. Individual Results May Vary.

TAMPER EVIDENT PACKAGE

DO NOT USE IF FOIL SEAL IS MISSING OR BROKEN.

211407

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a sudden change in bowel habits that persists for two weeks
  • abdominal pain, nausea, or vomiting
Other Information (citrucel Orange) (Other information (Citrucel Orange))
  • each heaping tablespoon contains:calcium 80 mg, potassium 105 mg, sodium 10 mg
  • each heaping tablespoon contributes 60 calories from sucrose and maltodextrin
  • store below 25°C (77°F)
  • protect contents from humidity
  • keep tightly closed
Inactive Ingredients (citrucel Orange) (Inactive ingredients (Citrucel Orange))

citric acid, dibasic calcium phosphate, FD&C yellow #6 lake, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin, soy lecithin, sucrose, titanium dioxide, tricalcium phosphate

Other Information (citrucel Sugar Free) (Other information (Citrucel Sugar Free))
  • each rounded tablespoon contains:calcium 80 mg, potassium 120 mg, sodium 15 mg
  • each rounded tablespoon contributes 30 calories from maltodextrin
  • store below 25°C (77ºF)
  • protect contents from humidity
  • keep tightly closed
  • Phenylketonurics: CONTAINS PHENYLALANINE 48.6 mg per adult dose
Questions Or Comments? (citrucel Orange) (Questions or comments? (Citrucel Orange))

1-800-897-6081

Great Tasting

CITRUCEL Orange

DIRECTIONS FOR USE (NO SCOOP DOSING):

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

2. Measure heaping tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly.

Inactive Ingredients (citrucel Sugar Free) (Inactive ingredients (Citrucel Sugar Free))

aspartame, dibasic calcium phosphate, FD&C yellow #6 lake, malic acid, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin

Questions Or Comments? (citrucel Sugar Free) (Questions or comments? (Citrucel Sugar Free))

1-800-897-6081

DIRECTIONS FOR USE (NO SCOOP DOSING):

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

2. Measure rounded tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly.

Stop Use and Ask A Doctor If (citrucel Orange) (Stop use and ask a doctor if (CITRUCEL Orange))
  • constipation lasts more than 7 days
  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • These could be signs of a serious condition.
Stop Use and Ask A Doctor If (citrucel Sugar Free) (Stop use and ask a doctor if (CITRUCEL Sugar Free))
  • constipation lasts more than 7 days
  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • These could be signs of a serious condition.
Active Ingredient (in Each Heaping Tablespoon) Citrucel Orange (Active ingredient (in each heaping tablespoon) CITRUCEL Orange)

Methylcellulose (a non-allergenic fiber) 2 g

Active Ingredient (in Each Rounded Tablespoon) Citrucel Sugar Free (Active ingredient (in each rounded tablespoon) CITRUCEL Sugar Free)

Methylcellulose (a non-allergenic fiber) 2 g


Advanced Ingredient Data


Raw Label Data

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