Label: CITRUCEL- methylcellulose (4000 mpa.s) tablet
- Packager: GlaxoSmithKline Consumer Healthcare LP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient (in each caplet)
Methylcellulose (a non-allergenic fiber) 500mgClose
Bulk-forming fiber laxativeClose
- 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.
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 77 oF (25 oC)
- 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 sulfateClose
- 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.
GlaxoSmithKline Consumer Healthcare L.P.
Moon Township, PA 15108Close
- Principal Display Panel
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.
- INGREDIENTS AND APPEARANCE
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) (METHYLCELLULOSE (4000 MPA.S)) 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 ORANGE Score no score Shape FREEFORM (Caplet) Size 19mm Flavor Imprint Code CIT Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0199-01 180 in 1 BOTTLE; Combination Product Type = C112160 02/01/2010 2 NDC:0135-0199-02 100 in 1 BOTTLE; Combination Product Type = C112160 02/01/2010 3 NDC:0135-0199-06 2 in 1 POUCH; Combination Product Type = C112160 02/01/2010 4 NDC:0135-0199-07 240 in 1 BOTTLE; Combination Product Type = C112160 02/01/2010 5 NDC:0135-0199-08 50 in 1 CARTON 02/01/2010 5 NDC:0135-0199-06 2 in 1 POUCH; Combination Product Type = C112160 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 02/01/2010 Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)