Label: DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled

  • 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 September 1, 2021

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

  • Drug Facts

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

  • Purpose

    Stool softener laxative

  • Uses

    • for relief of occasional constipation (irregularity)
    • This generally produces a bowel movement within 12 to 72 hours.

  • Warnings

    Ask a doctor before use if you have
    • abdominal pain, nausea, or vomiting
    • a sudden change in bowel habits that lasts over 14 days

    Ask a doctor or pharmacist before use if you are presently taking mineral oil

    Stop use and ask a doctor if
    • you have rectal bleeding or no bowel movement after using this product.
    These can be signs of a serious condition
    • you need to use a laxative for more than 1 week

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

    Keep out of reach of children
    Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    • take softgels with a full glass (8 oz) of water

    adults and children 12 years of age and oldertake 1 to 3 softgels daily or as directed
    by a doctor. This dose may be taken as a single daily dose or in divided doses.
    children 6 to under 12 years of agetake 1 softgel daily or as directed by a doctor
    children under 6 years of ageask a doctor

  • Other information

    each softgel contains: sodium 10 mg (very low sodium)
    • store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F).

  • Inactive ingredients

    edible white ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution

  • Questions or comments? 

    (800)616-2471

  • SPL UNCLASSIFIED SECTION

    MAJOR®

    Unit Dose

    READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Distributed by:
    MAJOR® PHARMACEUTICALS
    Livonia, MI 48152

    Product of UAE
    Packaged and Quality Assured in the USA

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

  • Packaging

    Major1

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7183
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 777
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7183-6110 in 1 CARTON09/04/2021
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/04/2021
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Strive Pharmaceuticals Inc. (080028013)