Label: CITRUCEL- methylcellulose (4000 mpa.s) powder, for solution 

  • Label RSS
  • NDC Code(s): 0135-0089-69, 0135-0089-71, 0135-0090-70, 0135-0090-74, view more
    0135-0090-75
  • Packager: GlaxoSmithKline Consumer Healthcare LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/14

If you are a consumer or patient please visit this version.

  • Active ingredient CITRUCEL® Orange

    (in each heaping tablespoon)

    Methylcellulose (a non-allergenic fiber) 2g

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  • Active ingredient Citrucel® Sugar Free

    (in each rounded tablespoon)

    Methylcellulose (a non-allergenic fiber) 2g

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  • Purpose

    Bulk-forming fiber laxative

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  • 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
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  • 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.

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  • 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

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  • 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

     

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  • 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
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  • 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

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  • 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

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  • Questions or comments?

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

     

     Citrucel® is a registered trademark of the Sanofi group of companies and licensed by the GlaxoSmithKline group of companies.

    For more information on Citrucel®, visit citrucel.com.

    Distributed by:

    GlaxoSmithKline Consumer Healthcare, L.P.

    Moon Township, PA 15108

     

     CITRUCEL® Orange

     

    DIRECTIONS FOR USE (NO SCOOP** DOSING):

    Image of pouring water into glass

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

    Image of stirring water after adding Citrucel

    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.

    CITRUCEL® Sugar Free


    DIRECTIONS FOR USE (NO SCOOP** DOSING):

    Image of pouring water into glass

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

    Image of stirring water after adding Citrucel

    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.

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  • Principal Display Panel

    NDC 0135-0089-69

    CITRUCEL®

    METHYLCELLULOSE FIBER THERAPY FOR REGULARITY

    Great Taste

    Gentle and clinically proven effective
    Gives you additional fiber to help balance your diet
    The ONLY fiber for regularity that won’t cause excess gas*

    orange FLAVOR

    NET WT 16 OZ (454 GRAMS)

    Great-Tasting

    CITRUCEL® Orange

    Citrucel's unique because it is:

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

    *Based on laboratory testing. Individual results may vary.

    5E643 SB F4

    ©2012 GlaxoSmithKline

    62063XF

    Citrucel Orange 16 oz label
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  • Principal Display Panel

    NDC 0135-0090-74

    CITRUCEL®

    METHYLCELLULOSE FIBER THERAPY FOR REGULARITY

    Great Taste

    Gentle and clinically proven effective
    Gives you additional fiber to help balance your diet
    The ONLY fiber for regularity that won’t cause excess gas*

     sugar free ORANGE FLAVOR

    NET WT 32 OZ (907 GRAMS)

    Great-Tasting Orange Flavor

    CITRUCEL® Sugar Free

    Citrucel's unique because it is:

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

    *Based on laboratory testing. Individual results may vary.

    5M245 SB F4

    ©2012 GlaxoSmithKline

    62056XG

    Citrucel Orange Sugar Free 32 oz label
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  • INGREDIENTS AND APPEARANCE
    CITRUCEL 
    methylcellulose powder, for solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0135-0089
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHYLCELLULOSE (4000 MPA.S) (METHYLCELLULOSE (4000 MPA.S)) METHYLCELLULOSE (4000 MPA.S) 2 g  in 19 g
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    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
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0089-69 454 g in 1 BOTTLE; Combination Product Type = C112160 09/16/2010
    2 NDC:0135-0089-71 850 g in 1 BOTTLE; Combination Product Type = C112160 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 LABEL Item Code (Source) NDC:0135-0090
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHYLCELLULOSE (4000 MPA.S) (METHYLCELLULOSE (4000 MPA.S)) METHYLCELLULOSE (4000 MPA.S) 2 g  in 10.2 g
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    FD&C YELLOW NO. 6  
    MALIC ACID  
    MALTODEXTRIN  
    POTASSIUM CITRATE  
    RIBOFLAVIN  
    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; Combination Product Type = C112160 09/16/2010
    2 NDC:0135-0090-74 907 g in 1 BOTTLE; Combination Product Type = C112160 09/16/2010
    3 NDC:0135-0090-75 1191 g in 1 BOTTLE; Combination Product Type = C112160 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 LP (828924212)
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