CITRUCEL- methylcellulose (4000 mpa.s) tablet 
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 (in each caplet)

Methylcellulose (a non-allergenic fiber) 500mg

Purpose

Bulk-forming fiber laxative

Uses

helps restore and maintain regularity
relieves constipation (irregularity)
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

Take 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 case choking. See choking warning.

Age

Dose

Maximum Dose

adults & children 12 years of age and over

start with 2 caplets. Increase as needed up to 6 times per day.

do not exceed 12 caplets per day

children 6 - 11 years of age

start with 1 caplet. Increase as needed up to 6 times per day.

do not exceed 6 caplets per day

children under 6 years of age

consult a physician

consult a physician

Other information

each caplet contains: calcium 10mg
store below 77oF (25oC)
protect contents from humidity
keep tightly closed

Inactive ingredients

crospovidone, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate

Questions or comments?

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

TAMPER EVIDENT PACKAGE

BOTTLE SEALED WITH PRINTED FOIL UNDER CAP.

DO NOT USE IF FOIL IS MISSING OR BROKEN.

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

Patent Nos. 6350469, 7125562, 6372253, 7132114.

Distributed by:

GlaxoSmithKline Consumer Healthcare L.P.

Moon Township, PA 15108

Principal Display Panel

NDC 0135-0199-02

CITRUCEL®

METHYLCELLULOSE FIBER THERAPY FOR REGULARITY

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

100 Fiber caplets

BETTER VALUE Per Dose than leading competition

*Based on laboratory testing. Individual results may vary.

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

©2012 GlaxoSmithKline

101878XA

Citrucel 100 count caplet label
CITRUCEL 
methylcellulose tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0199
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLCELLULOSE (4000 MPA.S) (METHYLCELLULOSE (4000 MPA.S)) METHYLCELLULOSE (4000 MPA.S)500 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C YELLOW NO. 6 
ALUMINUM OXIDE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
POVIDONES 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorORANGEScoreno score
ShapeFREEFORM (Caplet) Size19mm
FlavorImprint Code CIT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0199-01180 in 1 BOTTLE; Combination Product Type = C11216002/01/2010
2NDC:0135-0199-02100 in 1 BOTTLE; Combination Product Type = C11216002/01/2010
3NDC:0135-0199-062 in 1 POUCH; Combination Product Type = C11216002/01/2010
4NDC:0135-0199-07240 in 1 BOTTLE; Combination Product Type = C11216002/01/2010
5NDC:0135-0199-0850 in 1 CARTON02/01/2010
5NDC:0135-0199-062 in 1 POUCH; Combination Product Type = C112160
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/01/2010
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 9/2014
Document Id: f64029c6-e697-4e6b-a69e-47e004cd6f73
Set id: d27f6742-2dcc-451e-b803-6ffe183038ec
Version: 8
Effective Time: 20140916
 
GlaxoSmithKline Consumer Healthcare LP