Label: DOCUSATE SODIUM liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 2, 2024

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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 older

    5 to 20 mL (1 to 4 teaspoonfuls)

    children 6 to under 12 years of age

    5 to 10 mL (1 to 2 teaspoonfuls)

    children 3 to under 6 years of age

    2.5 to 5 mL (1/2 to 1 teaspoonful)

    children under 3 years

    ask 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:

    Overbagged with 5 x 10 mL unit dose cups in each bag, NDC 55154-2346-5

  • 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

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L58458961223

  • Principal Display Panel

    DOCUSATE SODIUM LIQUID

    100 MG / 10 mL

    5 CUPS

    Bag Label
  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-2346(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, UNSPECIFIED FORM (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:55154-2346-55 in 1 BAG12/26/2023
    110 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 DrugM00712/26/2023
    Labeler - Cardinal Health 107, LLC (118546603)
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