Label: SENNA-S- sennosides 8.6mg and docusate sodium 50mg tablet, film coated

  • NDC Code(s): 73057-378-07, 73057-378-08, 73057-378-11
  • Packager: Ulai Health LLC
  • 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 January 31, 2022

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  • Active Ingredients (in each tablet)

    Sennosides 8.6 mg

    Docusate Sodium 50 mg

  • Purpose

    Laxative

    Stool Softener

  • Uses

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

    Do not use

    • if you are taking mineral oil, unless directed by a doctor
    • 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 the 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 (1-800-222-1222).

  • Directions

    • take preferably at bedtime or as directed by a doctor

    age

    starting dosage

    maximum dosage

    adults and children 12 years and over

    2 tablets once a day 

     4 tablets twice a day

    children 6 to under 12 years

    1 tablet once a day

     2 tablets twice a day

    children 2 to under 6 years 

    1/2 tablet once a day

     1 tablet twice a day

    children under 2 years

    ask a doctor

     ask a doctor

  • Other information

    • each tablet contains:  calcium 10 mg, sodium 5 mg, Very Low Sodium
    • store at 20-25°C(68-77°F); excursions permitted between 15 o-30 oC (59 o-86 oF)
  • Inactive ingredients

    croscarmellose sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc, titanium dioxide

  • Questions?

    (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

  • PRINCIPAL DISPLAY PANEL

    PHARBEST

    NDC 73057-378-11

    Manufactured in the USA

    *Compare to the active ingredients in Senokot-S ®

    SENNA-S

    Sennosides 8.6 mg &

    Docusate Sodium 50 mg

    Natural Vegetable Laxative

    Ingredient Plus Stool Softener

    1000 TABLETS

    Ulai Senna S 1000ct Label

  • INGREDIENTS AND APPEARANCE
    SENNA-S 
    sennosides 8.6mg and docusate sodium 50mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-378
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (ORANGE COLOR) Scoreno score
    ShapeROUND (ROUND TABLET) Size10mm
    FlavorImprint Code PH32
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73057-378-0760 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2019
    2NDC:73057-378-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2019
    3NDC:73057-378-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/10/2019
    Labeler - Ulai Health LLC (081181535)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(73057-378) , analysis(73057-378) , pack(73057-378) , label(73057-378)
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