Label: GOODSENSE SENNA- sennosides tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 19, 2012

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  • Active Ingredient

    Sennosides 8.6 mg

  • Purpose

    Laxative

  • Uses:

    Relieves occasional constipation (irregularity)

    Generally produces a bowel movement in 6 - 12 hours

  • WARNINGS

    Do not use Laxative products for longer than 1 week, unless directed by a doctor



    Ask a doctor befor use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that continues over a period of 2 weeks

    Stop use and ask a doctor

    if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

    If pregnant or breast feeding

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

    Other Information

    • each tablet contains: calcium 25 mg/tablet
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • do not use if imprinted safety seal under cap is broken or missing
    • This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®
  • Directions

    Take preferably at bedtime or as directed by a doctor.


    Age
    		Starting Dosage
    		Maximum Dosage
    adults and children 12 years of age or older
    		2tablets once a day
    		4 tablets twice a day
    children 6 to under 6 years
    		1 tablet once a day
    		2 tablets twice a day
    children 2 to under 6 years
    		1/2 tablet once a day
    		1 tablet twice a day
    children under 2 years
    		ask a doctor
    		ask a doctor
  • Inactive Ingredients

    Colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, *dicalcium phosphate anhydrous, hypermellose, maltodextrin, magnesium stearate, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG), stearic acid, talc, triacetin. 

    *May also contain.

  • Other Information

    each tablet contains calcium 25mg

    store at 25C. excursions permitted between 15-30C (59-86F)

  • Questions or Comments?

    Call toll free: 1877-753-3935 Monday-Friday 9AM - 5PM EST

    This product is not manufactured or distributed by Purdue Products, L.P., owner of th registered trademark Senokot.

    Proudly Distributed by

    Valu Merchandisers, Co.

    Kansas City, KS 66106

  • Product Labeling

    GoodSense

    Senna Laxative

    Standardsized Senna Concentrate, 8.6mg

    Natural Vegetable Laxtive Ingredient

    100 tablets 8.6mg each

    gssl

    1

  • INGREDIENTS AND APPEARANCE
    GOODSENSE SENNA 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-180
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code S3;S8;TCL080
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-180-011 in 1 BOX
    1100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33411/02/2012
    Labeler - Geiss, Destin & Dunn, Inc. (076059836)
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