Label: SENNA LAXATIVE- senna tablet, film coated

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

Drug Label Information

Updated October 3, 2023

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  • Active ingredient (in each tablet)

    Sennosides 8.6mg

  • 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:

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

  • Questions?

    Adverse drug event call: (866) 562-2756

  • 16 HOW SUPPLIED

    Senna Laxative Tablets are available as follows:

    8.6 mg: Brown, round, scored tablet, debossed “SB”. Available in bottles of

    10 tablets (NDC 43063-838-10)

    30 tablets (NDC 43063-838-30)

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    SENNA LAXATIVE 
    senna tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43063-838(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
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code S8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43063-838-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
    2NDC:43063-838-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00701/24/2007
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(43063-838)
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