Label: SENNA PLUS- 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 February 14, 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 1 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 2 weeks

    Stop use and ask a doctor if you have

    • no bowel movement within 12 hours
    • rectal bleeding
    • these could 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 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 6 mg
    • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
    • store at room temperature

  • Inactive ingredients

    cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, PEG, sodium benzoate, stearic acid, titanium dioxide. May also contain D&C yellow #10, FD&C yellow #5 (tartrazine), magnesium silicate, mineral oil, silica, sodium lauryl sulfate, starch, triacetin, wax.

  • HOW SUPPLIED

    NDC: 71335-1181-1: 30 Tablets in a BOTTLE

    NDC: 71335-1181-2: 120 Tablets in a BOTTLE

    NDC: 71335-1181-3: 60 Tablets in a BOTTLE

    NDC: 71335-1181-4: 90 Tablets in a BOTTLE

    NDC: 71335-1181-5: 100 Tablets in a BOTTLE

    NDC: 71335-1181-6: 28 Tablets in a BOTTLE

    NDC: 71335-1181-7: 56 Tablets in a BOTTLE

    NDC: 71335-1181-8: 14 Tablets in a BOTTLE

    NDC: 71335-1181-9: 20 Tablets in a BOTTLE

  • 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:71335-1181(NDC:57896-458)
    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 SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code TCL081
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1181-130 in 1 BOTTLE; Type 0: Not a Combination Product04/07/2021
    2NDC:71335-1181-2120 in 1 BOTTLE; Type 0: Not a Combination Product02/05/2020
    3NDC:71335-1181-360 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
    4NDC:71335-1181-490 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    5NDC:71335-1181-5100 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2019
    6NDC:71335-1181-628 in 1 BOTTLE; Type 0: Not a Combination Product04/08/2019
    7NDC:71335-1181-756 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    8NDC:71335-1181-814 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    9NDC:71335-1181-920 in 1 BOTTLE; Type 0: Not a Combination Product02/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2000
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1181) , RELABEL(71335-1181)
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