Label: SENNA-LAX- 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 October 4, 2016

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

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  • ACTIVE INGREDIENTS (IN EACH TABLET)

    Sennosides 8.6 mg

  • PURPOSE

    Laxative

  • USES

    •
    for relief of occasional constipation and irregularity
    •
    this product produces a 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 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 longer than 1 week unless directed by a doctor

    Stop use and ask a doctor

    rectal bleeding or failure to have a bowel movement occur after use of a laxative. These could be 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

    •
    Take preferably at bedtime or as directed by doctor
    •
    If you do not have a comfortable bowel movement by the second day, increase dose by 1 tablet (do not exceed maximum dosage) or decrease dose until you are comfortable
     Age Starting dosage Maximum dosage
     Adults and children over 12 years 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

     consult a doctor

     
  • OTHER INFORMATION

    •
    each tablet contains: calcium 50 mg
    •
    store at 20°-25°C (68°-77°F)

    You may report serious side effects to: 1-888-952-0050.

  • INACTIVE INGREDIENTS

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

  • PRINCIPAL DISPLAY PANEL

    Senna-Lax

    Senna Lax

    Repackaged By: Preferred Pharmaceuticals Inc.

     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
     
      
  • INGREDIENTS AND APPEARANCE
    SENNA-LAX 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9685(NDC:0603-0282)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TARTARIC ACID (UNII: W4888I119H)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code AZ217
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-9685-330 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2013
    2NDC:68788-9685-1100 in 1 BOTTLE; Type 0: Not a Combination Product03/28/2013
    3NDC:68788-9685-660 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/28/2013
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals, Inc.791119022REPACK(68788-9685)
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