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 October 9, 2019

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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)
    • generally produces 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 -you have 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 7 mg

    • store at room temperature

  • Inactive ingredients

    cellulose, croscarmellose sodium, dicalcium phosphate, FD and C yellow no. 5 (tartrazine), FD and C yellow no. 6, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, titanium dioxide, triacetin

  • PRINCIPAL DISPLAY PANEL

    DRUG: Senna Plus

    GENERIC: Sennosides and Docusate Sodium

    DOSAGE: TABLET

    ADMINSTRATION: ORAL

    NDC: 70518-1590-0

    COLOR: yellow

    SHAPE: ROUND

    SCORE: No score

    SIZE: 10 mm

    IMPRINT: CPC490

    PACKAGING: 30 in 1 BLISTER PACK

    ACTIVE INGREDIENT(S):

    • DOCUSATE SODIUM 50mg in 1
    • SENNOSIDES 8.6mg in 1

    INACTIVE INGREDIENT(S):

    • CELLULOSE, MICROCRYSTALLINE
    • SODIUM BENZOATE
    • FD&C YELLOW NO. 6
    • SODIUM LAURYL SULFATE
    • FD&C YELLOW NO. 5
    • TITANIUM DIOXIDE
    • STARCH, CORN
    • STEARIC ACID
    • CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
    • CROSCARMELLOSE SODIUM
    • HYPROMELLOSES
    • MAGNESIUM SILICATE
    • MAGNESIUM STEARATE
    • POLYETHYLENE GLYCOLS
    • MINERAL OIL
    • TRIACETIN

    Remedy_Label

  • INGREDIENTS AND APPEARANCE
    SENNA PLUS 
    sennosides and docusate sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1590(NDC:57896-455)
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSES (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)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code CPC490
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70518-1590-030 in 1 BLISTER PACK; Type 0: Not a Combination Product10/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/25/2018
    Labeler - REMEDYREPACK INC. (829572556)
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