Docusate Sodium Capsule, Liquid Filled
FDA Label NDC 72789-166

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pd-rx Pharmaceuticals, Inc. for the product Docusate Sodium (NDC 72789-166). 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 (in each softgel), purpose, uses, warnings do not use:, ask a doctor before use, stop use and ask a doctor, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener

Uses

  • For the relief of occasional constipation.
  • Helps to prevent dry, hard stools.
  • This product generally produces a bowel movement within 12 to 72 hours.

Warnings Do Not Use:

  • If you are currently taking mineral oil, unless directed by a doctor.
  • When abdominal pain, nausea, or vomiting are present.
  • For longer than one week unless directed by a doctor.

Ask A Doctor Before Use

if you notice a sudden change in bowel habits that persists over a period of two weeks.

Stop Use And Ask A Doctor

if you have rectal bleeding or you fail to have a bowel movement after use.

If Pregnant Or Breast-Feeding,

ask a healthcare professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (800) 222-1222.

Directions

Adults and Children over 12 years of age

Take orally 1 softgel preferably at bedtime for
2-3 days or until bowel movements are normal, or as directed by a doctor.

Children under 12 years of age

Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information

  • Each softgel contains 13 mg of Sodium.
  • Store at room temperature between 15°C to 25°C (59°F to 77°F).
  • Do not use if seal under cap is broken or missing.

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol.

Questions

Quwstions of Comments Call 1 (800) 682-9862

How Supplied

For identification purposes, each softgel will have an imprint that reads NV12.

NDC 72789-166-60 Bottles of 60 softgels.

Package/Label Principal Display Panel

Docusate Sodium, USP
Stool Softener
250 mg Each

72789166 Label (72789166)

72789166 Label (72789166)

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