Label: SENNA- sennosides 8.6mg 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 December 28, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Sennosides 8.6mg

  • 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 one week unless directed by a doctor

  • Ask a doctor before 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 could be signs of a serious condition.
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of childen.

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Take preferably at bedtime or as directed by a doctor
    AgeStarting DosageMaximum Dosage
    Adults and children 12 years of age and over2 tablets once a day4 tablets twice a day
    Children 6 to under 12 years1 tablet once a day2 tablets twice a day
    Children 2 to under 6 years½ tablet once a day1 tablet twice a day
    Children under 2 yearsask a doctorask a doctor
  • Other information:

    • Each tablet contains: calcium 50mg
    • Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide.

  • Principal Display Panel

    Senna Tablet

    Sennosides 8.6mg

    Lot: 22A0161

    Exp: 2024-11-22

    PKG BY: Safecor Health

    Woburn, MA

    Rev A

    image description
  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides 8.6mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-130(NDC:69168-371)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48433-130-01100 in 1 BOX12/01/2022
    11 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 finalpart33412/01/2022
    Labeler - Safecor Health, LLC (828269675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC078805287repack(48433-130) , relabel(48433-130)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!