Label: SENNA-PLUS- sennosides and docusate sodium tablet

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

Drug Label Information

Updated April 4, 2024

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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

    Age
    		Starting Dose
    		Maximum Dose
    adults and children 12 years of age and older
    		2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor
    		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
      Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
    • product of India

  • Inactive ingredients

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

  • HOW SUPPLIED

    NDC: 71335-1674-1: 30 Tablets in a BOTTLE

    NDC: 71335-1674-2: 120 Tablets in a BOTTLE

    NDC: 71335-1674-3: 60 Tablets in a BOTTLE

    NDC: 71335-1674-4: 90 Tablets in a BOTTLE

    NDC: 71335-1674-5: 100 Tablets in a BOTTLE

    NDC: 71335-1674-6: 28 Tablets in a BOTTLE

    NDC: 71335-1674-7: 56 Tablets in a BOTTLE

    NDC: 71335-1674-8: 14 Tablets in a BOTTLE

    NDC: 71335-1674-9: 20 Tablets in a BOTTLE

    Repackaged/Relabeled by:

    Bryant Ranch Prepack, Inc.

    Burbank, CA 91504

  • PRINCIPAL DISPLAY PANEL

    Docusate/ Sennosides 50/8.6 mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    SENNA-PLUS 
    sennosides and docusate sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1674(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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code PSD22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1674-130 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2021
    2NDC:71335-1674-2120 in 1 BOTTLE; Type 0: Not a Combination Product08/18/2020
    3NDC:71335-1674-360 in 1 BOTTLE; Type 0: Not a Combination Product09/23/2020
    4NDC:71335-1674-490 in 1 BOTTLE; Type 0: Not a Combination Product04/04/2024
    5NDC:71335-1674-5100 in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
    6NDC:71335-1674-628 in 1 BOTTLE; Type 0: Not a Combination Product08/24/2020
    7NDC:71335-1674-756 in 1 BOTTLE; Type 0: Not a Combination Product04/04/2024
    8NDC:71335-1674-814 in 1 BOTTLE; Type 0: Not a Combination Product04/04/2024
    9NDC:71335-1674-920 in 1 BOTTLE; Type 0: Not a Combination Product04/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/01/2019
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1674) , RELABEL(71335-1674)
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