Docusate Sodium Liquid
FDA Label NDC 53807-216

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rij Pharmaceutical Corporation for the product Docusate Sodium Liquid (NDC 53807-216). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (per teaspoonful = 5 ml), purpose, uses, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per Teaspoonful = 5 Ml)

Docusate Sodium 50 mg

Purpose

Stool Softener

Uses

  • prevents / relieves dry hard stool
  • results usually occur 1 to 3 days after the first dose

Warnings

Do not use
  • when abdominal pain, nausea, or vomiting are present
  • for more than one week unless directed by a doctor
    • Ask a doctor before use if you
    • are taking mineral oil
    • have noticed a sudden change in bowel habits that lasts more than 2 weeks
      • Stop use and ask a doctor if
      • you have no bowel movement within 3 days
      • you have rectal bleeding
        • these could be signs of a serious condition
      • a skin rash occurs
      • you experience throat irritation

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, seek professional assisstance or contact a Poison Control Center immediately.

Directions


  • follow dosing directions below or take as directed by doctor
  • must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation
  • may be taken as a single daily dose or in divided doses
  • take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
  • do not exceed recommended dose
  • shake well before using
    • Adults and children 12 years and over
    		1 to 4 teaspoons (50 to 200 mg)
    Children under 12 years of age
    		ask a doctor

    1 teaspoon = 5 mL


    TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.


    Other information
    • Store at room temperature 15°-30°C (59°-86°F)
    • protect from excessive heat
    • Keep tightly closed
    • Dispense in tight, light resistant container as defined in the USP
    • each teaspoon (5 mL) contains: sodium 15 mg

Inactive Ingredients

citric acid, D&C Red #33, flavor, parabens, poloxamer, propylene glycol, sodium citrate, sorbitol, sucrose, and water.

Package Label.Principal Display Panel

Container Label (Container)

Container Label (Container)

* Please review the disclaimer below.