Stool Softener
FDA Label NDC 70005-015

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Stool Softener (NDC 70005-015). 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, otc - purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - 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

Other

Drug Facts

Otc - Purpose

Active ingredient (in each softgel)                 Purpose

Docusate sodium 100 mg..............................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.

Do Not Use

■ if you are presently 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

Ask A Doctor Before Use If You Have

noticed a sudden change in bowel habits that continues over a period of 2 weeks

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 over: take 1 to 3 softgels daily. This dose may be taken as single daily dose or in divided doses.

■ children 2 to under 12 years of age: take 1 softgels daily

■ children under 2 years of age: consult a physician.

Other Information

■ each softgel contains sodium 6 mg

■ store at controlled room temperature 15°-30°C (59°-86°F)

■ read all product information before using

Inactive Ingredients

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

Principal Display Panel

Compare to the Active Ingredients in Dulcolax® Stool Softener

STOOL SOFTENER

Docusate Sodium Softgels, 100 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Softgels Each

Principal Display Panel (50 Pouch Box)

Principal Display Panel (50 Pouch Box)

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