Label: CITRUCEL- methylcellulose (4000 mpa.s) tablet 

  • Label RSS
  • NDC Code(s): 0135-0199-01, 0135-0199-02, 0135-0199-06, 0135-0199-07, view more
    0135-0199-08
  • 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 (in each caplet)

    Methylcellulose (a non-allergenic fiber) 500mg

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  • Purpose

    Bulk-forming fiber laxative

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  • Uses

    helps restore and maintain regularity
    relieves constipation (irregularity)
    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

    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 case 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

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  • Other information

    each caplet contains: calcium 10mg
    store below 77 oF (25 oC)
    protect contents from humidity
    keep tightly closed
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  • Inactive ingredients

    crospovidone, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate

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  • Questions or comments?

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

    TAMPER EVIDENT PACKAGE

    BOTTLE SEALED WITH PRINTED FOIL UNDER CAP.

    DO NOT USE IF FOIL IS MISSING OR BROKEN.

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

    Patent Nos. 6350469, 7125562, 6372253, 7132114.

    Distributed by:

    GlaxoSmithKline Consumer Healthcare L.P.

    Moon Township, PA 15108

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  • Principal Display Panel

    NDC 0135-0199-02

    CITRUCEL®

    METHYLCELLULOSE FIBER THERAPY FOR REGULARITY

    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

    100 Fiber caplets

    BETTER VALUE Per Dose than leading competition

    *Based on laboratory testing. Individual results may vary.

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

    ©2012 GlaxoSmithKline

    101878XA

    Citrucel 100 count caplet label
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  • INGREDIENTS AND APPEARANCE
    CITRUCEL 
    methylcellulose tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0135-0199
    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) 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSPOVIDONE  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    FD&C YELLOW NO. 6  
    ALUMINUM OXIDE  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    POVIDONES  
    SODIUM LAURYL SULFATE  
    Product Characteristics
    Color ORANGE Score no score
    Shape FREEFORM (Caplet) Size 19mm
    Flavor Imprint Code CIT
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0199-01 180 in 1 BOTTLE; Combination Product Type = C112160 02/01/2010
    2 NDC:0135-0199-02 100 in 1 BOTTLE; Combination Product Type = C112160 02/01/2010
    3 NDC:0135-0199-06 2 in 1 POUCH; Combination Product Type = C112160 02/01/2010
    4 NDC:0135-0199-07 240 in 1 BOTTLE; Combination Product Type = C112160 02/01/2010
    5 NDC:0135-0199-08 50 in 1 CARTON 02/01/2010
    5 NDC:0135-0199-06 2 in 1 POUCH; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 02/01/2010
    Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)
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