CITRUCEL- methylcellulose tablet

CITRUCEL by

Drug Labeling and Warnings

CITRUCEL by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

GSKConsumer Healthcare

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

NDC: 0135-0199-01

CITRUCEL

METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY

Easy Flip Top Cap

• Gentle and clinically proven effective*
• Gives you additional fiber to help relieve occasional constipation
• Fiber for regularity that won’t cause excess gas**

180 Fiber caplets

105120XC

INGREDIENTS AND APPEARANCE

CITRUCEL 
methylcellulose tablet

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 (15 MPA.S AT 5%) (UNII: 68401960MK)
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)