Label: DOCUSATE SODIUM liquid

  • NDC Code(s): 0121-0935-05, 0121-0935-16, 0121-0935-40, 0121-1870-00, view more
    0121-1870-10
  • Packager: PAI Holdings, LLC dba PAI Pharma
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 6, 2025

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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 0121-0935-16: 16 fl oz (473 mL) bottle
    NDC 0121-0935-05: 5 mL unit dose cup, in a tray of ten cups.
    NDC 0121-1870-10: 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

    MANUFACTURED BY

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    R12/20

  • PRINCIPAL DISPLAY PANEL - 16 fl oz (473 ML)

    NDC 0121-0935-16

    Docusate Sodium Liquid

    50 mg/5 mL

    STOOL SOFTENER LAXATIVE

    Alcohol Free/Sugar Free

    16 fl oz (473 mL)

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    X0935160721 R07/21

    16 fl oz (473 mL) bottle label
  • PRINCIPAL DISPLAY PANEL - 5 mL Cup LIdding

    NDC 0121-0935-05

    Docusate Sodium Liquid

    50 mg/5 mL

    STOOL SOFTENER LAXATIVE

    Alcohol Free/Sugar Free

    Package Not Child-Resistant

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    5 mL unit dose cup
  • PRINCIPAL DISPLAY PANEL - 10 mL Cup Lidding

    NDC 0121-1870-10

    Docusate Sodium Liquid

    100 mg/10 mL

    STOOL SOFTENER LAXATIVE

    Alcohol Free/Sugar Free

    Package Not Child-Resistant

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    10 mL unit dose cup
  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0935
    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:0121-0935-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/16/202110/31/2025
    2NDC:0121-0935-404 in 1 CASE08/16/2021
    210 in 1 TRAY
    2NDC:0121-0935-055 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 DrugM00708/16/2021
    DOCUSATE SODIUM 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1870
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg  in 10 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
    Colorpurple (Clear pink to purple-pink) Score    
    ShapeSize
    FlavorCHERRY (Cherry-Vanilla) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-1870-0010 in 1 CASE08/16/2021
    110 in 1 TRAY
    1NDC:0121-1870-1010 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 DrugM00708/16/2021
    Labeler - PAI Holdings, LLC dba PAI Pharma (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma097630693analysis(0121-0935, 0121-1870) , label(0121-0935, 0121-1870) , manufacture(0121-0935, 0121-1870)
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