Label: GERICARE DOCUSATE SODIUM LIQUID- docusate sodium liquid

  • NDC Code(s): 57896-413-16
  • Packager: GERI-CARE PHARMACEUTICALS, CORP
  • 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 July 4, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients (per 5 mL)

    Docusate Sodium 50 mg

  • PURPOSE

    Purpose

    Stool Softener

  • INDICATIONS & USAGE

    Uses

    • Relief of occasional constipation (irregularity)
    • generally produces bowel movement in 12 to 72 hours
  • WARNINGS

    Warnings

    Do not use for more than one week unless directed by a doctor.

    Ask a doctore before use if you

    • have stomach pain, nausea or vomiting
    • hadve sudden change in bowel habits that persits over a period of 2 weeks
    • are taking mineral oil

    Stop use and ask doctor if

    • you have rectal bleeding or fail to have a bowel movement afrer use of this product. These could be signs of a serious condition.
    • a skin rash occurs
    • you experience throat irritation
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a doctor before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    shake well before using

    • follow dosing directions below or use as directed by a physician
    • do not exceed recommended dose
    • must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation
    • may be taken as a single daily dose or in dividend dose
    • take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response

    1 teasponnful = 5 mL

     Age Dose
     Adults and children over 12 years of age 1 to 6 teaspoons (5 mL - 30 mL)
     Children under 12 years of age Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, sodium benzoate, sodium citrate, sucralose

  • QUESTIONS

    Questions or comments? 1-800-540-3765

  • PRINCIPAL DISPLAY PANEL

    docusate

    docusate

  • INGREDIENTS AND APPEARANCE
    GERICARE DOCUSATE SODIUM LIQUID 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-413
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-413-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/01/2020
    Labeler - GERI-CARE PHARMACEUTICALS, CORP (611196254)