Label: DOCUSATE SODIUM liquid

  • NDC Code(s): 0121-0544-10, 0121-0544-16, 0121-0544-25
  • 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 January 19, 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° - 25°C (68° - 77°F)
    • Protect from freezing
    • Protect from light
    • Purple colored, cherry flavored liquid supplied in the following:
    NDC 0121-0544-16:16 fl oz (473 mL) bottle
    NDC 0121-0544-10:10 mL unit dose cup. Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each.
    NDC 0121-0544-25:25 mL unit dose cup. Case contains 100 unit dose cups of 25 mL packaged in 10 trays of 10 unit dose cups each.
  • Inactive ingredients

    Citric acid, D&C Red No. 33, flavoring, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.

  • Questions or comments?

    Call 1-800-845-8210

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    R11/20

  • PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

    NDC 0121-0544-10

    Docusate Sodium Liquid
    (SUGAR FREE)

    100 mg/10 mL

    STOOL SOFTENER LAXATIVE

    USUAL DOSAGE: See attached Drug Facts

    This unit-dose package is not child-resistant.

    Store at 20° - 25°C (68° - 77°F)
    [See USP Controlled Room Temperature].

    10 x 10 mL Unit-Dose Cups

    Pharmaceutical Associates, Inc.

    Greenville, SC 29605

    T0544101120       R11/20

    PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0544
    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
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0544-1612 in 1 CASE02/16/1983
    1473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0121-0544-1010 in 1 CASE02/16/1983
    210 in 1 TRAY
    210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:0121-0544-2510 in 1 CASE02/16/1983
    310 in 1 TRAY
    325 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 finalpart33402/16/1983
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693manufacture(0121-0544)
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