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CITRUCEL

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient CITRUCEL Orange

(in each heaping tablespoon)

Methylcellulose (a non-allergenic fiber) 2g

Active ingredient Citrucel Sugar Free

(in each rounded tablespoon)

Methylcellulose (a non-allergenic fiber) 2g

Purpose

Bulk-forming fiber laxative

CITRUCEL 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

Stop use and ask a doctor if

  • •constipation lasts more than 7 days
  • •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.

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 & 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 physician

CITRUCEL® Sugar Free

Age

Dose

adults & 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 physician

Other information (Citrucel Orange)

  • each heaping tablespoon contains: calcium 80mg and potassium 110mg
  • •each heaping tablespoon contributes 60 calories from sucrose and maltodextrin
  • •store below 77°F (25°C)
  • •protect contents from humidity
  • •keep tightly closed

 

Other information (Citrucel Sugar Free)

  • each rounded tablespoon contains: calcium 85mg and potassium 125mg
  • •each rounded tablespoon contributes 24 calories from maltodextrin
  • •store below 77°F (25°C)
  • •protect contents from humidity
  • •keep tightly closed
  • Phenylketonurics: CONTAINS PHENYLALANINE 52mg per adult dose

Inactive ingredients (Citrucel Orange)

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

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?

call toll-free 1-800-897-6081 (English/Spanish) weekdays

 

 Citrucel® is a registered trademark of the Sanofi group of companies and licensed by the GlaxoSmithKline group of companies.

For more information on Citrucel®, visit citrucel.com.

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

 

 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.

**We are as concerned about the environment as you are so we have removed the scoop from our Citrucel powder products. Doing so helps save energy, reduce the amount of plastic produced and improve environmental footprints.

CITRUCEL ® Sugar Free


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.

**We are as concerned about the environment as you are so we have removed the scoop from our Citrucel powder products. Doing so helps save energy, reduce the amount of plastic produced and improve environmental footprints.

Principal Display Panel

NDC 0135-0089-69

CITRUCEL®

METHYLCELLULOSE FIBER THERAPY FOR REGULARITY

Great Taste

  • •Gentle and clinically proven effective
  • •Gives you additional fiber to help balance your diet
  • •The ONLY fiber for regularity that won’t cause excess gas*

orange FLAVOR

NET WT 16 OZ (454 GRAMS)

Great-Tasting

CITRUCEL ® Orange

Citrucel's unique because it is:

  • Gentle and clinically proven effective to help restore and maintain regularity.
  • The ONLY fiber that won't ferment to cause excess gas like other fiber products.*
  • 100% soluble, non-allergenic and gluten-free.

*Based on laboratory testing. Individual results may vary.

5E643 SB F4

©2012 GlaxoSmithKline

62063XF

Principal Display Panel

NDC 0135-0090-74

CITRUCEL®

METHYLCELLULOSE FIBER THERAPY FOR REGULARITY

Great Taste

  • •Gentle and clinically proven effective
  • •Gives you additional fiber to help balance your diet
  • •The ONLY fiber for regularity that won’t cause excess gas*

 sugar free ORANGE FLAVOR

NET WT 32 OZ (907 GRAMS)

Great-Tasting Orange Flavor

CITRUCEL ® Sugar Free

Citrucel's unique because it is:

  • Gentle and clinically proven effective to help restore and maintain regularity.
  • The ONLY fiber that won't ferment to cause excess gas like other fiber products.*
  • 100% soluble, non-allergenic and gluten-free.

*Based on laboratory testing. Individual results may vary.

5M245 SB F4

©2012 GlaxoSmithKline

62056XG

CITRUCEL

methylcellulose POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0089
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
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C YELLOW NO. 6
maltodextrin
POTASSIUM CITRATE
RIBOFLAVIN
SUCROSE
titanium dioxide
TRICALCIUM PHOSPHATE

Product Characteristics

Color
ORANGE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0089-69 454 in 1 BOTTLE
2 NDC:0135-0089-71 850 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-09-16


CITRUCEL

methylcellulose POWDER, FOR SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0090
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
ASPARTAME
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C YELLOW NO. 6
Malic Acid
maltodextrin
POTASSIUM CITRATE
RIBOFLAVIN

Product Characteristics

Color
ORANGE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0090-70 479 in 1 BOTTLE
2 NDC:0135-0090-74 907 in 1 BOTTLE
3 NDC:0135-0090-75 1191 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-09-16


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Be sure to consult your doctor before taking any medication!
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