Extra Strength Stool Softener Laxative
FDA Label NDC 66336-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dispensing Solutions, Inc. for the product Extra Strength Stool Softener Laxative (NDC 66336-010). 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 if, stop use and ask a doctor if, if pregnant or breastfeeding, 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 250mg

Purpose

Stool softener

Uses

  • Relieves occasional constipation.
  • Generally produces bowel movement within 12 to72 hours.

Warnings - Do Not Use

  • for longer than one week
  • if you are taking mineral oil
  • when abdominal pain, nausea, or vomiting are present

Ask A Doctor Before Use If

you have a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop Use And Ask A Doctor If

  • you experience rectal bleeding
  • you fail to have a bowel movement after using this product

    • These may indicate a serious condition.

If Pregnant Or Breastfeeding

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • adults and children over 12 years and over:1 capsule once daily
  • children under 12 years: ask a doctor

Other Information

  • store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)

    • Each capsule contains sodium 15mg

Inactive Ingredients

edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

Questions Or Comments?

Call 1-800-645-2158, 9am - 5am ET Monday - Friday

Product Labeling

Rugby Extra Strength Stool Softener Laxative
Docusate Sodium USP, 250mg

Mfd for: Rugby Laboratories, Inc
Duluth Georgia 30097
www.rugbylaboratories.com

Package Label

NDC 66336-0010-XX

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