Docusate Sodium Liquid
FDA Label NDC 54859-813

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceuticals International Division for the product Docusate Sodium Liquid (NDC 54859-813). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients (per 5 mL)

Docusate Sodium 50 mg

Otc - Purpose

Purpose

Stool Softener

Indications & Usage

Uses

Relief of occasional constipation

Warnings

Warnings

Do not use when

  • abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • for more than one week unless directed by a doctor

    • Ask a doctore before use if you

    • are taking mineral oil
    • have noticed a sudden change in bowel habits that last more than two weeks

      • Stop use and ask doctor if

      • you have no bowel movements 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 doctor before use

Otc - 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

  • follow dosing directions below or use as directed by a physician
  • 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
  • do not exceed recommended dose
  • shake well before using

    • 1 teasponnful = 5 mL

     Age Dose
     Adults and children over 12 years of age 1 to 6 teaspoons (50 mg - 300 mg)
     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

Otc - Questions

Questions or comments? 1-866-595-5598

Package Label.Principal Display Panel

Docusatesodium (Ducosate)

Docusatesodium (Ducosate)

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