Label: SENNA- sennosides 8.6 mg tablets tablet

  • NDC Code(s): 71406-105-01, 71406-105-10
  • Packager: AACE PHARMACEUTICALS, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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  • SPL UNCLASSIFIED SECTION

    Senna Tablets

    Sennosides 8.6 mg

    AACE Pharmaceuticals, Inc.

    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.

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Sennosides 8.6 mg

  • PURPOSE

    Laxative

  • USES

    • relieves 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 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 may indicate a serious condition.

    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.

  • DIRECTIONS

    • take preferably at bedtime or as directed by a doctor

    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 docto

  • OTHER INFORMATION

    • each tablet contains: calcium 4 mg, sodium 3 mg
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • INACTIVE INGREDIENTS

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid

  • PRINCIPAL DISPLAY PANEL

    ​†Compare to the active ingredient in Senokot®

    Senna Tablets

    Sennosides 8.6 mg

    Natural Vegetable Laxative

    Gentle, Overnight Relief of Constipation

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Manufactured by:

    AACE Pharmaceuticals, Inc. Fairfield, NJ 07004

    aacepharma.com

    †This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot®.

    NDC 71406-105-10

    NDC 71406-105-01

  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides 8.6 mg tablets tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71406-105
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorbrown (Light brown to grey) Scorescore with uneven pieces
    ShapeROUNDSize9mm
    FlavorImprint Code S5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71406-105-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/30/2019
    2NDC:71406-105-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/30/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00708/30/2019
    Labeler - AACE PHARMACEUTICALS, INC. (080630748)
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