Label: GENTLE LAXATIVE 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 October 10, 2021

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  • Drug Facts

    Gentle Laxative 

  • Purpose 

    Stimulant Laxative

  • Active Ingerient (in each tablet)

    Bisacodyl 5mg

  • Uses

    • For temporary relief of occasional constipation and irregularity
    • This product generally produces a bowel movement in 6 to 12 hours
  • Warnings

    Do not use

    • If you cannot swallow without chewing
  • Ask a doctor before use if you have

    • stomach pain, nausea or vomiting
    • a sudden change in bowel habits that last more than 2 weeks
  • When using this product

    • Do not chew or crush tablet(s)
    • Do not use within 1 hour after taking an antacid or milk 
    • It may cause stomach discomfirt, faintness and cramps
  • Stop use and ask a doctor if

    • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition
    • you need to use a laxative for more than 1 week
  • 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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    • Take with a glass of water 
    • Adults and children 12 years of age and over : Take 1 to 3 tablets in a single daily dose
    • Children 6 to under 12 years of age: Take 1 tablet in a single daily dose
    • Children under 6 years of age: Ask a doctor
  • Other Information

    • Store at controlled room temperature 20°- 25°C  (68°- 77°F)
    • Read all product information before using 
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 
  • Inactive ingredients

    • Colloidal silicon dioxide
    • Croscarmellose sodium
    • Dicalcium phosphate 
    • FD&C Blue#1
    • FD&C Blue#2
    • Magnesium Stearate
    • Microcrystalline cellulose
    • Polyethylene glycol
    • Polyvinyl alcohol
    • Talc
    • Titanium dioxide
  • Questions or comments?

    Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

  • Gentle Laxative Bisacodyl 5 mgCompare to Dulcolax® Laxative active ingredients Distributed by: Healthlife of USA LLCRahwayNJ 07065www.healthlifeofusa.com

    Gentle laxative

  • INGREDIENTS AND APPEARANCE
    GENTLE LAXATIVE 
    gentle laxative tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-116
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-116-241 in 1 CARTON05/31/2017
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/31/2017
    Labeler - Healthlife of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Laboratiries, Inc.037052099manufacture(69517-116) , pack(69517-116)
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