CITRUCEL description, usages, side effects, indications, overdosage, supplying and lots more!

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CITRUCEL

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Methylcellulose (a non-allergenic fiber) 500mg

Bulk-forming fiber laxative

  • •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

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.

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

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

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

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

methylcellulose TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0199
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
METHYLCELLULOSE (4000 MPA.S) 500 mg

Inactive Ingredients

Ingredient Name Strength
CROSPOVIDONE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C YELLOW NO. 6
ALUMINUM OXIDE
MAGNESIUM STEARATE
maltodextrin
POVIDONES
SODIUM LAURYL SULFATE

Product Characteristics

Color Size Imprint Code Shape
ORANGE 19 mm CIT FREEFORM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0199-01 180 in 1 BOTTLE
2 NDC:0135-0199-02 100 in 1 BOTTLE
3 NDC:0135-0199-06 2 in 1 POUCH
4 NDC:0135-0199-07 240 in 1 BOTTLE
5 NDC:0135-0199-06 2 in 1 POUCH
6 NDC:0135-0199-08 50 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-02-01


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