Label: CITRUCEL- methylcellulose tablet

  • NDC Code(s): 0135-0199-01, 0135-0199-02, 0135-0199-06, 0135-0199-07, view more
    0135-0199-08, 0135-0199-09
  • 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 April 26, 2022

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  • 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 77 oF (25 oC)
    • 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

    105120XC_Citrucel Caplets_180 caps.JPG
  • INGREDIENTS AND APPEARANCE
    CITRUCEL 
    methylcellulose tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0199
    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)500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    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
    ColororangeScoreno score
    ShapeFREEFORM (Caplet) Size19mm
    FlavorImprint Code CIT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0199-01180 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2010
    2NDC:0135-0199-02100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2010
    3NDC:0135-0199-062 in 1 POUCH; Type 0: Not a Combination Product02/01/2010
    4NDC:0135-0199-07240 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2010
    5NDC:0135-0199-0850 in 1 CARTON02/01/2010
    5NDC:0135-0199-062 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:0135-0199-091 in 1 PACKAGE02/15/2017
    6240 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/01/2010
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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