Docusate Sodium
FDA Label NDC 59105-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by J.p. Business Enterprise for the product Docusate Sodium (NDC 59105-007). 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 other, active ingredient (in each softgel), purpose, uses, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed By: J.P Business Enterprise
Lake Grove, NY 11755

Active Ingredient (In Each Softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

  • for prevention of dry, hard stools
  • for relief of occasional constipation

    • This product generally produces a bowel movement within 12 to 72 hours.

Otc - Do Not Use

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 1 week, unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Otc - Stop Use

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use

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 overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take with a glass of water
    • adults and children 12 years of age and overtake 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
    children 2 to under 12 years of agetake 1 softgel daily
    children under 2 years of ageconsult a physician

Other Information

  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive Ingredients

FD&C Red # 40, FD&C Yellow #6, gelatin, glycerine, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide (for printing)

Questions Or Comments?

Call toll free: 1-888-333-9792

Principal Display Panel - 50 Softgel Bottle Carton

VALUMEDS

Compare to the active ingredient in
Dulcolax ® Stool Softener

STOOL SOFTENER
DOCUSATE SODIUM 100 MG

  • GENTLE RELIEF
  • EFFECTIVE
  • STIMULANT FREE

    • 50 SOFTGELS

    Principal Display Panel (50 Softgel Bottle Carton)

    Principal Display Panel (50 Softgel Bottle Carton)

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