Label: LAXACIN- docusate sodium and sennosides tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)

    Docusate Sodium 50 mg

    Sennosides 8.6 mg

  • PURPOSE

    Purposes

    Stool softener

    Laxative

  • INDICATIONS & USAGE

    Uses

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

    Warnings

  • DO NOT USE

    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 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

    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.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    •
    take preferably at bedtime or as directed by a doctor

    age

    starting dose

    maximum dose

    adults and children 12

    years and older

    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

    ask a doctor

    ask a doctor
  • STORAGE AND HANDLING

    Other information

    •
    each tablet contains: calcium 20 mg, sodium 4 mg
    •
    keep lid tightly closed
    •
    store at room temperature in a dry place
  • INACTIVE INGREDIENT

    Inactive ingredients Croscarmellose sodium, D&C yellow #10, dextrose, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica, sodium benzoate, stearic acid, titanium dioxide.

  • QUESTIONS

    Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 495-6078

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Alexso Inc.

    Los Angeles, CA 90064

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LAXACIN 
    docusate sodium and sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-930(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, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G55
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55700-930-00100 in 1 BOTTLE; Type 0: Not a Combination Product09/10/202108/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00709/10/202108/31/2024
    Labeler - Quality Care Products, LLC (831276758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Quality Care Products, LLC831276758relabel(55700-930)
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