Gericare Docusate Sodium Liquid
FDA Label NDC 57896-423

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceuticals, Corp for the product Gericare Docusate Sodium Liquid (NDC 57896-423). 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, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredients (per 5 mL)

Docusate Sodium 50 mg

Otc - Purpose

Purpose

Stool Softener

Indications & Usage

Uses

  • relieves 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

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

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

Otc - Questions

Questions or comments? 1-800-540-3765

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