Label: DOCUSATE SODIUM- docusate sodium liquid liquid

  • NDC Code(s): 0121-0935-05, 0121-0935-16, 0121-0935-40, 0121-1870-00, view more
    0121-1870-10
  • Packager: Pharmaceutical Associates, Inc.
  • 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 15, 2021

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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

    PRINCIPAL DISPLAY PANEL - 16 fl oz (473 mL)

  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Tray Label

    NDC 0121-0935-05

    Docusate Sodium Liquid

    50 mg/5 mL

    STOOL SOFTENER LAXATIVE

    Alcohol Free/Sugar Free

    Package Not Child-Reistant

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    PRINCIPAL DISPLAY PANEL - 5 mL Cup Tray Label

  • PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

    NDC 0121-1870-10

    Docusate Sodium Liquid

    100 mg/10 mL

    STOOL SOFTENER LAXATIVE

    Alcohol Free/Sugar Free

    Package Not Child-Reistant

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium liquid 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 Product08/16/2021
    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 not finalpart33408/16/2021
    DOCUSATE SODIUM 
    docusate sodium liquid 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 not finalpart33408/16/2021
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-0935, 0121-1870)
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