Label: SENNA- sennosides tablet, film coated

  • NDC Code(s): 71399-8245-1, 71399-8245-2, 71399-8245-3
  • Packager: Akron Pharma Inc.
  • 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 March 18, 2023

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  • Drug Facts

    Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally causes a bowel movement in 6-12 hours
  • WARNINGS

    Do not use

    • laxative products for longer than one week unless directed by a doctor

    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 may indicate a serious condition.

    If pregnant or breast-feeding,

    ask a health care 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 and older

    2 tablets

    once a day

    4 tablets

    twice a day

    Children 6 to under

    12 years of age

    1 tablet

    once a day

    2 tablets

    twice a day

    Children 2 to under

    6 years of age

    1/2 tablet

    once a day

    1 tablet

    twice a day

    Children under

    2 years of age

    ask a doctor

    ask a doctor

  • Other information

    • Each tablet contains: Calcium 14 mg
    • Store between 15º to 30ºC (59 to 86F)
  • Inactive ingredients

    microcrystaline cellulose, dicalcium phosphate, sodium starch glycolate, croscarmellose sodium, hypromellose, povidone, collodial silicon dioxide, megnesium stearate. 

  • Questions or comments?

    1-(877) 255-6999

  • SPL UNCLASSIFIED SECTION

    Tamper Evident:

    Do not use if imprinted inner safety seal is torn or missing.

    This product is not manufactured or distributed by Purdue Products L.P.,

    Owner of the registered trademark Senokot®

    Manufactured for:

    Akron Pharma Inc

    Fairfield, NJ 07004

    www.akronpharma.com

  • PRINCIPAL DISPLAY PANEL

    UD

    8.6

  • INGREDIENTS AND APPEARANCE
    SENNA 
    sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-8245
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code AP45
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-8245-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/10/2021
    2NDC:71399-8245-21000 in 1 BOTTLE; Type 0: Not a Combination Product05/10/2021
    3NDC:71399-8245-3100 in 1 PACKAGE01/01/2023
    31 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/10/2021
    Labeler - Akron Pharma Inc. (067878881)
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