Label: GOODSENSE FIBER- 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 November 29, 2022

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  • ACTIVE INGREDIENT(in each caplet)

    Methylcellulose 500 mg

  • PURPOSE

    Bulk-forming laxative

  • USE(S)

    • relieves occasional constipation to help restore and maintain regularity
    • 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

    • abdominal pain, nausea or vomiting
    • a sudden change in bowel habits that persists over a period of 2 weeks
  • WHEN USING THIS PRODUCT

    • do not use laxative products for a period longer than one week unless directed by a doctor.
    • do not use if you are on a low salt diet unless directed by a doctor.
  • STOP USE AND ASK DOCTOR IF

    • rectal bleeding occurs
    • you fail to have a bowel 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

  • 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.

     AGE DOSEMAXIMUM DOSE 
     adults & children 12 years & over 2 caplets up to 6 times daily
     children 6 to 11 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 below 25oC (77oF)
    • protect contents from moisture
    • keep tightly closed
  • INACTIVE INGREDIENTS

    citric acid, colloidal silicondioxide, crospovidone, FD&C yellow no.6 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, sodium chloride, sodium lauryl sulfate.

  • PRINCIPAL DISPLAY PANEL

    NDC 50804-364-16
    GOODSENSE'
    Bulk Forming Laxative
    FiberCaplets
    METHYLCELLULOSE CAPLETS
    Fiber Therapy for Regularity
    Compare to active ingredient of Citrucel Caplets
    100 Caplets



    188-GS-100
  • INGREDIENTS AND APPEARANCE
    GOODSENSE FIBER 
    methylcellulose tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-364
    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, UNSPECIFIED (UNII: 2S7830E561)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code G188
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-364-16100 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33412/01/2015
    Labeler - GoodSense (076059836)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(50804-364)
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