Label: CITRUCEL- methylcellulose tablet
0135-0199-07, view more0135-0199-08, 0135-0199-09
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 9, 2021
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- Active ingredient (in each caplet)
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.
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.
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
- Inactive ingredients
- Questions or comments?
Additional information found on label
TAMPER EVIDENT PACKAGE
BOTTLE SEALED WITH PRINTED FOIL UNDER CAP.
DO NOT USE IF FOIL IS MISSING OR BROKEN.
Warren, NJ 07059
*When Used As Directed.
**Based On Laboratory Testing.
Individual Results May Vary.
Trademarks are owned by or licensed to the GSK group of companies
©2018 GSK or its licensor.
- Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0199 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 MPA.S) - UNII:MRJ667KA5E) METHYLCELLULOSE (4000 MPA.S) 500 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) 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; Type 0: Not a Combination Product 02/01/2010 2 NDC:0135-0199-02 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2010 3 NDC:0135-0199-06 2 in 1 POUCH; Type 0: Not a Combination Product 02/01/2010 4 NDC:0135-0199-07 240 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2010 5 NDC:0135-0199-08 50 in 1 CARTON 02/01/2010 5 NDC:0135-0199-06 2 in 1 POUCH; Type 0: Not a Combination Product 6 NDC:0135-0199-09 1 in 1 PACKAGE 02/15/2017 6 240 in 1 BOTTLE; Type 0: Not a Combination Product 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 Holdings (US) LLC (079944263)