Label: GNP FIBER THERAPY- methylcellulose tablet

  • 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 15, 2016

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  • Active ingredient (in each caplet)

    Methylcellulose 500 mg

  • Purpose

    Bulk-forming laxative

  • Uses

    • helps restore and maintain regularity and relieves constipation (irregularity)
    • in the treatment of constipation associated with other bowel disorders when recommended by a doctor
  • 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

    When using this product

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

    Stop use and ask a doctor if

    • rectal bleeding occurs
    • you fail to have a bowel movement after use
  • Keep out of reach of children

    In case of overdose, get medical help or contact a poison control center right away.

  • Directions

    This product generally produces effect in 12-72 hours

    take this product (child or adult) dose with atleast 8 ounces (a full glass) of water or other fluid

    taking this product without enough liquid may cause choking, see choking warning

     AGEDOSE MAXIMUM DOSE 
     adults and children over 12 years    2 caplets up to 6 times daily
     children (6 to 12 years) 1 caplet up to 6 times daily
     children under 6 years ask a doctor          ask a doctor                  

  • Other information

    • each caplet contains: sodium 10 mg
    • store at room temperature 15o-30oC (59o-86oF)
    • protect contents from moisture
    • keep tightly closed
    • tamper evident: Do not use if printed seal under cap is torn or missing
  • Inactive ingredients

    citric acid, colloidal silicon dioxide, crospovidone, FD&C yellow 6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulphate

  • Principal Display Panel

    Good Neighbor Pharmacy

    compare to Citrucel caplets active ingredient

    fiber therapy

    Methylcellulose Fiber Laxativebulk-forming laxative

    easy to take with you

    gentle fiber for regularity

    daily source of 100% soluble fiber

    100 caplets

    BOX

  • INGREDIENTS AND APPEARANCE
    GNP FIBER THERAPY 
    methylcellulose tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-466
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYLCELLULOSE (4000 CPS) (UNII: MRJ667KA5E) (METHYLCELLULOSE (4000 CPS) - UNII:MRJ667KA5E) METHYLCELLULOSE (4000 CPS)500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (UNII: 68401960MK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code G188
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-466-781 in 1 CARTON09/09/2011
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/09/2011
    Labeler - Amerisource Bergen (007914906)
    Registrant - Guardian Drug Company (119210276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276manufacture(24385-466)
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