Topcare Stool Softener Capsule, Liquid Filled
FDA Label NDC 76162-761

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Stool Softener (NDC 76162-761). 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, do not use, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12 to 72 hours

Do Not Use

  • if you are presently taking mineral oil, unless told to do so by a doctor                                

Stop Use And Ask A Doctor If

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week

Directions

Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over

take 1 to 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

Other Information

  • each softgel contains: sodium 7 mg
  • store at room temperature 15° to 30°C (59° to 86°F)

Inactive Ingredients

FD&C RED NO. 40, FD&C YELLOW NO. 6, GELATIN BOVINE, GLYCEROL, POLYETHYLENE GLYCOL, PURIFIED WATER, SORBITOL.

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DISTRIBUTED BY
TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007

©TOPCO RSEA0621

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

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