Label: NATURAL SENNA LAXATIVE- sennosides 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 December 14, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    SENNOSIDES 8.6MG

  • Purpose

    LAXATIVE

  • Uses

    • for the relief of occasional constipation
    • generally causes bowel movement in 6 to 12 hours
  • Warnings

    Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

    Ask a doctor before use if you have

    • noticed a sudden change in bowel habits that persists over a period of 2 weeks.

    Ask a doctor or pharmacist before use if you

    • are taking a prescription drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after

    other drugs.

    When using this product

    • do not use for a period longer than 1 week.

    Stop use and ask a doctor if

    • rectal bleeding or failure to have a bowel movement occur 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 accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take preferably at bedtime or as directed by a doctor
    • If you do not have a confortable bowel movement by the second day, increase dosage by one tablet (do not exceed the maximum dosage) or decrease dose until you are confortable.
    adults and children 12 years and over
    • take 2 tablets once a day.
    • do not take more than 4 tablets twice a day.
    children 6 to under 12 years
    • take 1 tablet once a day.
    • do not take more than 2 tablets twice a day.
    children 2 to under 6 years
    • take 1/2 tablet once a day.
    • do not take more than 1 tablet twice a day.
    children under 2 years
    • ask a doctor

  • Other information

    • each tablet contains: calcium 40mg
    • store at room temperature
  • Inactive ingredients

    Collodial silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose.

  • Questions?

    937-898-4010

  • PRINCIPAL DISPLAY PANEL

    01bB_PDP_Natural Senna Laxative_8.6mg.jpg

    01b_DF1_Natural Senna Laxative_8.6mg.jpg

    01b_DF_Natural Senna Laxative_8.6mg.jpg

  • INGREDIENTS AND APPEARANCE
    NATURAL SENNA LAXATIVE 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0761-0790
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code AZ217
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0761-0790-02100 in 1 BOTTLE; Type 0: Not a Combination Product12/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/14/2021
    Labeler - Basic Drugs, Inc. (052155082)