FDA Label for Citrucel
View Indications, Usage & Precautions
Citrucel Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Caplet)
Methylcellulose (a non-allergenic fiber) 500mg
Purpose
Bulk-forming fiber laxative
Uses
• relieves occasional constipation (irregularity)• 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 cause 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
Additional Information Found On Label
TAMPER EVIDENT PACKAGE
BOTTLE SEALED WITH PRINTED FOIL UNDER CAP.
DO NOT USE IF FOIL IS MISSING OR BROKEN.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
Patent Nos. 6350469, 7125562, 6372253, 7132114.
©2012 GSK or its licensor.
*When Used As Directed.
**Based On Laboratory Testing.
Individual Results May Vary.
Among Top 5 National Brands.
Trademarks are owned by or licensed to the GSK group of companies
Principal Display Panel
NDC 0135-0199-02
CITRUCEL®
METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY
Easy Flip Top Cap
• Gentle and clinically proven effective*• Gives you additional fiber to help relieve occasional constipation• The ONLY fiber for regularity that won’t cause excess gas**
100 Fiber caplets
105118XB
* Please review the disclaimer below.