CITRUCEL- methylcellulose (4000 mpa.s) powder, for solution 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

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):

Image of pouring water into glass

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

Image of stirring water after adding Citrucel

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):

Image of pouring water into glass

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

Image of stirring water after adding Citrucel

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

Citrucel Orange 16 oz label

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 Orange Sugar Free 32 oz label
CITRUCEL 
methylcellulose powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0089
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLCELLULOSE (4000 MPA.S) (METHYLCELLULOSE (4000 MPA.S)) METHYLCELLULOSE (4000 MPA.S)2 g  in 19 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C YELLOW NO. 6 
MALTODEXTRIN 
POTASSIUM CITRATE 
RIBOFLAVIN 
SUCROSE 
TITANIUM DIOXIDE 
TRICALCIUM PHOSPHATE 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0089-69454 g in 1 BOTTLE; Combination Product Type = C11216009/16/2010
2NDC:0135-0089-71850 g in 1 BOTTLE; Combination Product Type = C11216009/16/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/16/2010
CITRUCEL 
methylcellulose powder, for solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0090
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLCELLULOSE (4000 MPA.S) (METHYLCELLULOSE (4000 MPA.S)) METHYLCELLULOSE (4000 MPA.S)2 g  in 10.2 g
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C YELLOW NO. 6 
MALIC ACID 
MALTODEXTRIN 
POTASSIUM CITRATE 
RIBOFLAVIN 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0090-70479 g in 1 BOTTLE; Combination Product Type = C11216009/16/2010
2NDC:0135-0090-74907 g in 1 BOTTLE; Combination Product Type = C11216009/16/2010
3NDC:0135-0090-751191 g in 1 BOTTLE; Combination Product Type = C11216009/16/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/16/2010
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 9/2014
Document Id: 58abe1e4-4a95-4ce5-968a-e08e2075311b
Set id: 9d5f2244-a610-4d45-b6e8-e79bb17a558f
Version: 5
Effective Time: 20140916
 
GlaxoSmithKline Consumer Healthcare LP