Label: FIBER THERAPY- methylcellulose powder, for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

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  • Active ingredient

    (in each 19g adult dose/ rounded tablespoon)

    Methylcellulose 2g (a non-allergenic fiber)

  • Purpose

    Bulk-forming fiber laxative

  • Uses

    •
    relieves constipation (irregularity)
    •
    helps to restore and maintain regularity
    •
    for treating bowel disorders when recommended by a doctor
    •
    generally provide effect 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

    •
    abdominal pain, nausea or vomiting
    •
    a sudden change in bowel habits that persists over a period of 2 weeks
    •
    sensitivity to any of the ingredients

    Stop use and ask a doctor if

    •
    you have rectal bleeding
    •
    you fail to have a bowl movement after use.
    •
    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 at 1-800-222-1222.

    When using this product

    •
    do not exceed recommended maximum daily dose unless directed by a doctor
    •
    do not use laxative products for a period longer than one week unless directed by a doctor 
  • 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

     Age

     Dose

     adults & children above 12 years of age and over

     One rounded tablespoon. (19 g) in 8 ounces of water fluid up to 3 times daily at the first sign of constipation or irregularity

     children 6 - 12 years of age

    Children under 6 years of age

     half the adult dose in 8 ounces of water once daily.

    ask a doctor
  • Other information

    •
    Each adult dose contains approximately
    •
    3mg of sodium
    •
    105mg potassium
    •
    contributes 60 calories from sucrose and sorbitol
    •
    store at room temperature
    •
    protect contents from humidity
    •
    keep tightly closed

        Tamper Evident: Do not use if printed seal under cap is torn or missing

  • Inactive ingredients

    citric acid, FD&C yellow 6 aluminum lake, maltodextrin, flavor (natural and artificial), potassium citrate, , silica, sucrose,

  • Questions or comments?

    call toll-free 1-800-616-2471

    *This product is not manufactured or distributed by GlaxoSmithKline the distributor of CITRUCEL®

    Distributed by:

    MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152, USA

    DIRECTIONS FOR USE

    Image of pouring water into glass

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

    Image of stirring water after adding Citrucel

    2. Add the adult or child dose listed in the directions. 3. Stir briskly until dissolved and drink promptly. Drinking an additional glass of water is helpful.

    TAMPER EVIDENT PACKAGE

    Do not use if printed seal under cap is torn or missing.

  • Principal Display Panel

    NDC 0904-5675-16

    FIBER THERAPY

    Methylcellulose

    Easy to Mix

    No Gritty Texture

    100% Soluble Fiber for Controlled Regularity

    ORANGE FLAVOR

    NET WT 16 OZ (454 GRAMS)

    Fiber Therapy
  • INGREDIENTS AND APPEARANCE
    FIBER THERAPY 
    methylcellulose powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5675
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    RIBOFLAVIN (UNII: TLM2976OFR)  
    SUCROSE (UNII: C151H8M554)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5675-16454 g in 1 BOTTLE; Type 0: Not a Combination Product04/18/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/18/2008
    Labeler - Major Pharmaceuticals (191427277)
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