Label: LAXACIN- docusate sodium and sennosides tablet

  • Category: HUMAN OTC DRUG LABEL

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 July 12, 2013

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • Purpose

    Stool Softener

    Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 6-12 hours
  • Warnings

    Do not use

    • if you are now taking mineral oil, unless directed by a doctor
    • laxative products for longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that continues over a period of 2 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.

    LOT#

    Exp. Date:

  • Directions

    • take preferably at bedtime or as directly by a doctor
    agestarting dosemaximum dose
    adults and children 12 years and older2 tablets once a day4 tablets twice a day

    Other information

    • Each tablet contains: Calcium 20 mg
    • Each tablet contains: Sodium 4 mg
    • Store at room temperature
    • Keep lid tightly closed in a dry place
    • Do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    Croscarmellose Sodium, D&C Yellow #10, Dextrose, Dicalcium Phosphate, FD&C Yellow #6, Hypromelose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Silica, Sodium Benzoate, Stearic Acid, Titanium Dioxide.

    Questions? If you have any questions or comments, or to report an adverse event, please contact (480) 253-9761.

    Manufactured for:
    Alexso Inc.
    Thousand Oaks, CA 91360

  • Package/Label Principal Display Panel

    NDC 68258-4985-00

    NDC 68258-4985-00

  • INGREDIENTS AND APPEARANCE
    LAXACIN 
    docusate sodium and sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68258-4985(NDC:50488-0901)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G55
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68258-4985-0100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/01/2011
    Labeler - Dispensing Solutions, Inc. (066070785)
    Registrant - PSS World Medical, Inc. (101822682)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dispensing Solutions, Inc.066070785relabel(68258-4985) , repack(68258-4985)