Label: CITRUCEL- methylcellulose powder, for solution

  • NDC Code(s): 0135-0089-69, 0135-0089-71, 0135-0090-70, 0135-0090-74, view more
    0135-0090-75
  • 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.

Drug Label Information

Updated May 24, 2021

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

  • Active ingredient CITRUCEL Sugar 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 80 mg and potassium 105mg
    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 80 mg and potassium 115 mg
    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? (Citrucel Orange)

    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 

    © 2020 GSK group of companies or its licensor.

    DIRECTIONS FOR USE (NO SCOOP DOSING):

    Image_pouring water_into glass.jpg

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

    Image_stirring water_after Citrucel.jpg

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

    Questions or comments? (Citrucel Sugar Free)

    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 

    ©2020 GSK or licensor.

    DIRECTIONS FOR USE (NO SCOOP DOSING):

    Image_pouring water_into glass.jpg

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

    Image_stirring water_after Citrucel.jpg

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

  • Principal Display Panel

    NDC 0135-0089-69

    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 16 OZ (454 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

    DO NOT USE IF FOIL SEAL IS MISSING OR BROKEN.

    5E643

    SE643 Citrucel Orange Flavor 16 ozs
  • Principal Display Panel

    NDC 0135-0090-74

    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 fiber
     
    *When Used As Directed.
     
    **Based On Laboratory Testing. Individual Results May Vary.

    TAMPER EVIDENT PACKAGE

    DO NOT USE IF FOIL SEAL IS MISSING OR BROKEN.

    5M245

    SM245 Citrucel Powder Orange Flavor 32 ozs
  • INGREDIENTS AND APPEARANCE
    CITRUCEL 
    methylcellulose powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0089
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 MPA.S) - UNII:MRJ667KA5E) METHYLCELLULOSE (4000 MPA.S)2 g  in 19 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorORANGEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0089-69454 g in 1 BOTTLE; Type 0: Not a Combination Product09/16/2010
    2NDC:0135-0089-71850 g in 1 BOTTLE; Type 0: Not a Combination Product09/16/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/16/2010
    CITRUCEL 
    methylcellulose powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0090
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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 NameStrength
    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
    ColorORANGEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0090-70479 g in 1 BOTTLE; Type 0: Not a Combination Product09/16/2010
    2NDC:0135-0090-74907 g in 1 BOTTLE; Type 0: Not a Combination Product09/16/2010
    3NDC:0135-0090-751191 g in 1 BOTTLE; Type 0: Not a Combination Product09/16/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/16/2010
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)