Label: SENNOSIDES AND DOCUSATE SODIUM tablet

  • 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 August 30, 2022

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  • Active ingredient (in each tablet)

    Docusate Sodium         50 mg
    Sennosides            8.6 mg

  • Purpose

    Stool softener
    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
    • have noticed a sudden change in bowel habits that lasts over two 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

    • do not exceed 8 tablets in 24 hours
    • Adults and children 12 years of age and older take 2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor; the maximum dose should be 4 tablets in the morning and 4 tablets at bedtime
    • Children under 12 years ask a doctor
  • Other information

    • each tablet contains: calcium 20 mg, sodium 3 mg
    • store at controlled room temperature
    • Keep this and all drugs out of reach of children.
    • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
  • Inactive ingredients

    cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

  • PACKAGING INFORMATION

    The drug product contained in this package is from NDC # 57896-555, Geri-Care Pharmaceuticals Corp.

    Distributed by:
    American Health Packaging, Columbus, Ohio 43217

    762201
    0462201/0621A

  • Package/Label Display Panel – Carton – 8.6 mg/50 mg

    8.6 mg/50 mg Sennosides and Docusate Sodium Tablets Carton

    NDC 60687- 622-01

    Sennosides* and Docusate Sodium Tablets
    Natural Vegetable Laxative with Stool Softener
    *Standardized Senna Concentrate

    8.6 mg/50 mg

    100 Tablets (10 x 10)

    Drug Facts
    Active ingredients (in each tablet)......................................................................Purpose
    Docusate Sodium 50 mg...............................................................................Stool softener
    Sennosides 8.6 mg............................................................................................... Laxative

    The drug product contained in this package is from
    NDC # 57896-555, Geri-Care Pharmaceuticals Corp.

    Distributed by:
    American Health Packaging, Columbus, Ohio 43217

    762201
    0462201/0621A

  • Package/Label Display Panel – Blister – 8.6 mg/50 mg

    8.6 mg/50 mg Sennosides and Docusate Sodium Tablet Blister

    Sennosides and Docusate
    Sodium Tablet
    Laxative/Stool Softener

    8.6 mg/50 mg

  • INGREDIENTS AND APPEARANCE
    SENNOSIDES AND DOCUSATE SODIUM 
    sennosides and docusate sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-622(NDC:57896-555)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code PSD22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60687-622-01100 in 1 BOX, UNIT-DOSE08/03/2021
    1NDC:60687-622-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/03/2021
    Labeler - American Health Packaging (929561009)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Health Packaging929561009repack(60687-622)
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