Label: HEB GENTLE LAXATIVE- bisacodyl suppository

  • 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 December 29, 2022

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  • Active ingredient

    Bisacodyl USP, 10 mg


  • Purpose

    Stimulant Laxative

  • Uses

    • For relief of occasional constipation and irregularity
    • -This product generally produces bowel movement in 15 minutes to 1 hour

  • Warnings

    For rectal use only.

  • ASK DOCTOR

    • stomach pain, nausea or vomiting
    • noticed a sudden change in bowel habits that persists over a period of two weeks

  • When using this product

    May cause abdominal discomfort, faintness, rectal burning, and mild cramps

  • STOP USE

    Stop use and ask a doctor if

    • if you have rectal bleeding or fail to have bowel movement after using a laxative. This may indicate a serious condition
    • you need to use a laxative for more than 1 week
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and older                           Children 6 to under 12 years                     Children under 6

    One suppository once daily                                                        1/2 suppository once daily                        Ask doctor.

    -Detach one suppository from the strip and remove from foil - Carefully insert one suppositry well into the rectum

    -Do not use more than once per day

  • Other Information

    •  do not store above 30°C (86°F)
  • Inactive Ingredients

    hydrogenated vegetable oil

  • PRINCIPAL DISPLAY PANEL

    image of display

  • INGREDIENTS AND APPEARANCE
    HEB GENTLE LAXATIVE 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-877
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg  in 2000 mg
    Inactive Ingredients
    Ingredient NameStrength
    FAT, HARD (UNII: 8334LX7S21) 1990 mg  in 2000 mg
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize34mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-877-082 in 1 CARTON06/05/2019
    140 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/05/2019
    Labeler - H E B (007924756)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories, Inc.097807374manufacture(37808-877)
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