Label: DOCUSATE SODIUM liquid

  • NDC Code(s): 0904-7279-66, 0904-7279-72
  • Packager: Major Pharmaceuticals
  • 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 December 8, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Docusate sodium 50 mg

  • Purpose

    Stool softener

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 12 to 72 hours
  • Warnings

    Do not use

    • if you are presently taking mineral oil, unless told to do so by a doctor

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that lasts over 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 could be signs of a serious condition.
    • you need to use a stool softener laxative for more than 1 week
    • rash occurs

    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

    • Dose once daily
    • take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste.
    adults and children 12 years and older5 to 20 mL (1 to 4 teaspoonfuls)
    children 6 to under 12 years of age5 to 10 mL (1 to 2 teaspoonfuls)
    children 3 to under 6 years of age2.5 to 5 mL (1/2 to 1 teaspoonful)
    children under 3 yearsask a doctor

  • Other information

    • • Sodium content: 14 mg/ 5 mL
      • Store at controlled room temperature, 20° to 25°C (68° to 77°F)
      • Protect from freezing
      • Protect from light
      • Clear pink to purple-pink colored, cherry flavored liquid supplied in the following:

    NDC 0904-7279-66: 10 mL unit dose cup, in a tray of ten cups.

  • Inactive ingredients

    artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.

  • Questions or comments?

    Call 1-800-845-8210

  • SPL UNCLASSIFIED SECTION

    R06/22

    Distributed by:

    MAJOR ® PHARMACEUTICALS 

    Indianapolis, IN 46268

  • PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

    NDC 0904-7279-66

    Docusate Sodium Liquid

    100 mg/10 mL

    STOOL SOFTENER LAXATIVE

    Alcohol Free/Sugar Free

    Delivers 10 mL

    See insert

    For Institutional Use Only

    MAJOR ® PHARMACEUTICALS

    Indianapolis, IN 46268

    F0935C100622

    PRINCIPAL DISPLAY PANEL - 10 mL Cup Lidding

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7279
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    Colorpink (Clear pink to purple-pink) Score    
    ShapeSize
    FlavorCHERRY (Cherry-Vanilla) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7279-7210 in 1 CASE12/05/2022
    110 in 1 TRAY
    1NDC:0904-7279-6610 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/16/2021
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0904-7279, 0904-7279)
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