Label: SENNA- sennosides tablet

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

Drug Label Information

Updated September 1, 2024

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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

    •
    Lasative 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 if you 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 right away.

  • 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

    age

    starting dosage

    maximum dosage

    adults and children 12 years of age or older

    2 tablets once a day

    4 tablets twice a day

    children 6 to under 12 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
  • PRINCIPAL DISPLAY PANEL

    NDC 82804-143-04

    Senna

    Sennosides 8.6 mg

    Natural Vegetable Laxative

    4 Tablets

    *Compare to the Active Ingredient in SENOKOT®

    82804-143-04
  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82804-143(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)  
    MICROCRYSTALLINE CELLULOSE (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:82804-143-044 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00708/01/2020
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(82804-143) , RELABEL(82804-143)
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