CITRUCEL- methylcellulose powder, for solution

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 CITRUCEL Orange

(in each heaping tablespoon)

Methylcellulose (a non-allergenic fiber) 2g

Active ingredient CITRUCELSugar Free

(in each rounded tablespoon)

Methylcellulose (a non-allergenic fiber) 2g

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

• MIX 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
• use product at the first sign of constipation or irregularity
• put one dose in a full glass of cold water
• stir briskly and drink promptly
• drinking another glass of water is helpful

CITRUCEL Orange

• Age:

  Dose

• adults & children 12 years of age and over:

  start with 1 heaping tablespoon. Increase as needed, 1 heaping tablespoon at a time, up to 3 times per day.

• children 6 - 11 years of age:

  start with 2.5 level teaspoons. Increase as needed, 2.5 level teaspoons at a time, up to 3 times per day.

• children under 6 years of age:

  consult a physician

CITRUCEL Sugar Free

• Age:

  Dose

• adults & children 12 years of age and over:

  start with 1 rounded tablespoon. Increase as needed, 1 rounded tablespoon at a time, up to 3 times per day.

• children 6 - 11 years of age:

  start with 2 level teaspoons. Increase as needed, 2 level teaspoons at a time, up to 3 times per day.

• children under 6 years of age:

  consult a physician

Other information (Citrucel Orange)

• each heaping tablespoon contains: calcium 80mg and potassium 110mg
• each heaping tablespoon contributes 60 calories from sucrose and maltodextrin
• store below 77°F (25°C)
• protect contents from humidity
• keep tightly closed

 

Other information (Citrucel Sugar Free)

• each rounded tablespoon contains: calcium 85mg and potassium 125mg
• each rounded tablespoon contributes 24 calories from maltodextrin
• store below 77°F (25°C)
• protect contents from humidity
• keep tightly closed
• Phenylketonurics: CONTAINS PHENYLALANINE 52mg per adult dose

Inactive ingredients (Citrucel Orange)

citric acid, dibasic calcium phosphate, FD&C yellow #6 lake, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin, sucrose, titanium dioxide, tricalcium phosphate

Inactive ingredients (Citrucel Sugar Free)

aspartame, dibasic calcium phosphate, FD&C yellow #6 lake, malic acid, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin

Questions or comments?

call toll-free 1-800-897-6081

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059 

© 2018 The GSK group of companies or its licensor.

CITRUCEL Orange

DIRECTIONS FOR USE (NO SCOOP DOSING):

1. Fill glass with at least 8 oz. of cold water.

2. Measure heaping tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly.

CITRUCEL Sugar Free

DIRECTIONS FOR USE (NO SCOOP DOSING):

1. Fill glass with at least 8 oz. of cold water.

2. Measure rounded tablespoon of product (one dose) and stir product into water. Stir briskly and drink promptly.

Principal Display Panel

NDC: 0135-0089-71

Great Taste

CITRUCEL

METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY

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

orange FLAVOR

NET WT 30 OZ (850 GRAMS)

Great Tasting

CITRUCEL Orange

Citrucel offers these great benefits:

• Gentle and clinically proven effective to help relieve occasional constipation*
• Fiber that won't ferment to cause excess gas **
• 100% Soluble, gluten-free, non-allergenic fiber
•   *When Used As Directed.
•   **Based On Laboratory Testing. Individual Results May Vary.

TAMPER EVIDENT PACKAGE

BOTTLE SEALED WITH PRINTED FOIL UNDER CAP. DO NOT USE IF FOIL IS MISSING OR BROKEN.

105079XC

Principal Display Panel

NDC: 0135-0090-75

Great Taste

CITRUCEL

METHYLCELLULOSE FIBER THERAPY FOR IRREGULARITY

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

sugar free ORANGE FLAVOR

NET WT 32 OZ (907 GRAMS)

Great Tasting Orange Flavor

CITRUCEL Sugar Free

Citrucel offers these great benefits:

• Gentle and clinically proven effective to help relieve occasional constipation*
• Fiber that won't ferment to cause excess gas**
• 100% Soluble, gluten-free, and non-allergenic
•   *When Used As Directed.
•   **Based On Laboratory Testing. Individual Results May Vary.

TAMPER EVIDENT PACKAGE

BOTTLE SEALED WITH PRINTED FOIL UNDER CAP. DO NOT USE IF FOIL IS MISSING OR BROKEN.

105086XC

INGREDIENTS AND APPEARANCE

CITRUCEL 
methylcellulose powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0089
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)	2 g  in 19 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
RIBOFLAVIN (UNII: TLM2976OFR)
SUCROSE (UNII: C151H8M554)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0089-69	454 g in 1 BOTTLE; Type 0: Not a Combination Product	09/16/2010
2	NDC: 0135-0089-71	850 g in 1 BOTTLE; Type 0: Not a Combination Product	09/16/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/16/2010

CITRUCEL 
methylcellulose powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0090
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)	2 g  in 10.2 g

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MALIC ACID (UNII: 817L1N4CKP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
RIBOFLAVIN (UNII: TLM2976OFR)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0090-70	479 g in 1 BOTTLE; Type 0: Not a Combination Product	09/16/2010
2	NDC: 0135-0090-74	907 g in 1 BOTTLE; Type 0: Not a Combination Product	09/16/2010
3	NDC: 0135-0090-75	1191 g in 1 BOTTLE; Type 0: Not a Combination Product	09/16/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/16/2010

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)