CITRUCEL - methylcellulose (4000 cps) powder, for solution 
GlaxoSmithKline Consumer Healthcare LP

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Drug Facts

Active ingredient orange

(in each rounded tablespoon)

Methylcellulose (a non-allergenic fiber) 2g

Active ingredient sugar free

(in each heaping tablespoon)

Methylcellulose (a non-allergenic fiber) 2g

Purpose

Bulk-forming fiber laxative

Uses

• relieves constipation (irregularity)
• helps to restore and maintain regularity
• for constipation associated with other bowel disorders like IBS when recommended by a doctor
• 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 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

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, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin, sucrose, titanium dioxide, tricalcium phosphate

CITRUCEL® Sugar Free

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

Questions or comments?

call toll-free 1-800-897-6081 (English/Spanish) weekdays

 CITRUCEL® Orange

Patent No. 4,626,287

4,671,823

4,732,917

CITRUCEL® Sugar Free

Patent No. 4,626,287

4,671,823

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2009 GlaxoSmithKline

Citrucel® is a registered trademark of the GlaxoSmithKline group of companies.

 

Great-Tasting Orange Flavor

 CITRUCEL® Orange

CITRUCEL® Sugar Free

with smartfiber®

Citrucel's unique smartfiber® is smart because it is:

• The ONLY fiber that won't ferment to cause excess gas like other fiber products. *
• Clinically proven effective to help restore and maintain regularity.
• Gentle enough for everyday use.
• 100% soluble, non-allergenic and gluten-free.

*Based on laboratory testing. Individual results may vary.

 

 

 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.

**We are as concerned about the environment as you are so we have removed the scoop from our Citrucel powder products. Doing so helps save energy, reduce the amount of plastic produced and improve environmental footprints.

62063XC

5E643 SB F1

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.

**We are as concerned about the environment as you are so we have removed the scoop from our Citrucel powder products. Doing so helps save energy, reduce the amount of plastic produced and improve environmental footprints.

62056XD

5M245 SB F1

Principal Display Panel

Great Taste & Clinically Proven Effective

CITRUCEL®

METHYLCELLULOSE FIBER THERAPY FOR REGULARITY

with smartfiber®

The Only Fiber for Regularity

That Won't Cause Excess Gas*

ORANGE FLAVOR

NET WT 16 OZ (454 GRAMS)

Principal Display Panel

Great Taste & Clinically Proven Effective

CITRUCEL®

METHYLCELLULOSE FIBER THERAPY FOR REGULARITY

with smartfiber®

The Only Fiber for Regularity

That Won't Cause Excess Gas*
sugar free ORANGE FLAVOR

NET WT 32 OZ (907 GRAMS)

CITRUCEL  methylcellulose   powder, for solution

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0135-0089 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLCELLULOSE (4000 CPS) (METHYLCELLULOSE (4000 CPS)) METHYLCELLULOSE (4000 CPS) 2 g  in 19 g

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE   ANHYDROUS DIBASIC CALCIUM PHOSPHATE   FD&C YELLOW NO. 6   MALTODEXTRIN   POTASSIUM CITRATE   RIBOFLAVIN   SUCROSE   TITANIUM DIOXIDE   TRICALCIUM PHOSPHATE

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

Packaging # NDC Package Description Multilevel Packaging 1 0135-0089-69 454 g In 1 BOTTLE None 2 0135-0089-71 850 g In 1 BOTTLE None

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 NDC Product Code (Source) 0135-0090 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLCELLULOSE (4000 CPS) (METHYLCELLULOSE (4000 CPS)) METHYLCELLULOSE (4000 CPS) 2 g  in 10.2 g

Inactive Ingredients Ingredient Name Strength ASPARTAME   ANHYDROUS DIBASIC CALCIUM PHOSPHATE   FD&C YELLOW NO. 6   MALIC ACID   MALTODEXTRIN   POTASSIUM CITRATE   RIBOFLAVIN

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

Packaging # NDC Package Description Multilevel Packaging 1 0135-0090-70 479 g In 1 BOTTLE None 2 0135-0090-74 907 g In 1 BOTTLE None 3 0135-0090-75 1191 g In 1 BOTTLE None

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 LP (828924212)

Revised: 10/2010GlaxoSmithKline Consumer Healthcare LP