Label: LAXACIN 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 August 28, 2019

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

  • SPL UNCLASSIFIED SECTION

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

    Drug Facts

    Manufactured for:

    Alexso Inc.

    Los Angeles, CA 90064

  • 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

  • PRINCIPAL DISPLAY PANEL

    497-71

  • INGREDIENTS AND APPEARANCE
    LAXACIN 
    laxacin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-497(NDC:50488-0901)
    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
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G55
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-497-71100 in 1 BOTTLE; Type 0: Not a Combination Product08/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/28/2019
    Labeler - Direct_Rx (079254320)
    Registrant - Direct_Rx (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    Direct_Rx079254320repack(61919-497)