Label: ONELAX- docusate sodium liquid

  • 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 August 13, 2023

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

  • Drug Facts Active ingredient (in each 5 mL)

    Docusate Sodium 50 mg

  • Purpose

    Stool Softner Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 12 to 72 hours
  • Warnings

    Do Not Use for more than one week unless directed by a doctor.

  • Ask a doctor before use if you

    • have stomach pain, nausea or vomiting
    • have sudden change in bowel habits that persists over a period of 2 weeks
    • are presently taking mineral oil
  • Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of this product. These could be signs of a serious condition.
    • a skin rash occurs
    • you experience throat irritation
  • if pregnant or breast-feeding, 

    ask doctor before use.

  • Keep out of reach of children

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

  • 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 fruiit juice to prevent throat irritation
    • take maximum dose daily until first bowel movement, dosage should then be reduced according to indivisual response

  • DOSAGE & ADMINISTRATION

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

  • Other information

    • wach teaspoonful (5 ml) contains: sodium 5 mg
    • store at room temperature 15o - 30oC (59o - 86oF)
    • protect from excessive heat
    • Pharmacist-preserve and dispense in a tight, light resistant container with a child resistant cap as defined in the USP
    • Temper -Evident: Do not use if foil over bottle opening is torn, broken, or missing
  • Inactive ingredients:

    Anhydrous citric acid, D&C red#33, Flavor vanilla, Glycerin, Methyl Paraben, Propylene glycol, Propyl paraben, Poloxamer 407, Purified water, Sodium benzoate, Sodium citrate, Sorbitol solution, Sucralose

  • Questions or comments?

    call toll-free 1-877-225-6999

    Manufactured for:
    Akron Pharma, Inc.
    Fairfield, NJ 07004
    www.akronpharma.com

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ONELAX 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0039
    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)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-0039-6473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/04/2023
    Labeler - Akron Pharma (067878881)