Label: SENNOSIDES tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Stimulant Laxative

  • Uses

    • relieve occasional constipation (irregularity)
    • this product generally produces a bowel movement in 6 to 12 hours
  • Warnings

    Do not use

    • Laxative products for longer than 1 week unless directed by a doctor
  • ASK 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

    Stop use and ask a doctor ifyou have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.In case of overdose, get medical help or contact a Posion Control Center immediately.

  • Other information

    • each tablet contains: calcium 4 mg, sodium 3 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients

    colloidal sillicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose

  • Questions or comments?

    Call 516-341-0666

    8:30am-4:30pm ET. Mon-Fri

  • Directions

    take preferably at bedtime or as directed by a doctor

    do not exceed maximum dosage

    agestarting dosagemaximum dosage
    adults and children 12 years of age or older2 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 years1/2 tablet once a day1 tablet twice a day
    children under 2 yearsask a doctorask a doctor


  • HOW SUPPLIED

    Sennosides are round light brown tablets and have a imprint of S5. They are available as follows:

    • Bottles of 10: 72789-283-10
    • Bottles of 30: 72789-283-30

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

    Dispense in a well-closed, light-resistant container as defined in the USP.

    Protect from light.

  • PRINCIPAL DISPLAY PANEL

    Sennosides 8.6 mg

    Natural Vegetable Laxative

    *Compare to the Active Ingredient in SENOKOT®

    image

  • INGREDIENTS AND APPEARANCE
    SENNOSIDES 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72789-283(NDC:69618-064)
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorbrown (light) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code S5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72789-283-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/22/2022
    2NDC:72789-283-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/24/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00708/01/2020
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(72789-283)
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