Label: SENNA TABS- senna tablet, film coated

  • 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 7, 2021

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  • Active ingredient (in each tablet)

    <list>Sennosides 8.6mg<list>

  • Purpose

    Laxative

  • Uses

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


    Do not use

    for more than one week unless directed by a doctor

    Ask a doctor before use if you

    • have abdominal pain, nausea, or vomiting
    • are taking mineral oil
    • noticed a sudden change in bowel habits that last over 2 weeks

    Stop use and ask a doctor if

    • you have no bowel movement within 12 hours
    • you have rectal bleeding

    These could be signs of 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

    • do not exceed recommended dose
    Age
    		Starting Dose
    		Maximum Dose
    adults and children 12 years of age and older
    		2 tablets once a day preferably at bedtime; increase if needed, or as directed by a doctor
    		4 tablets twice a day, in the morning and at bedtime
    children under 12 years
    		ask a doctor
    		ask a doctor
  • Other information

    • Tamper Evident: Do not use if safety seal under cap is broken or missing
    • each tablet contains: calcium 20 mg, potassium 70 mg
    • store at room temperature 
  • Inactive ingredients:

    <list>croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil<list>

  • Questions?

    Adverse drug event call: (866) 562-2756

  • PRINCIPAL DISPLAY PANEL

    s444

  • INGREDIENTS AND APPEARANCE
    SENNA TABS 
    senna tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-444(NDC:16103-363)
    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)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code S8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-444-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product01/01/2017
    2NDC:67046-444-6260 in 1 BLISTER PACK; Type 0: Not a Combination Product01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2017
    Labeler - Contract Pharmacy Services-PA (945429777)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coupler Enterprises Inc.945429777repack(67046-444)
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