Active Ingredient (In Each Softgel Capsule)
Docusate Sodium 100mg
Non-habit Forming Stool Softener
FDA Label NDC 33261-039
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidarex Pharmaceuticals Llc for the product Non-habit Forming Stool Softener (NDC 33261-039). 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 capsule), 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
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 or in divided doses
- children 6 to under 12 years: 1 capsule once daily
- children under 6 years: ask a doctor
Other Information
- store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)
Each capsule contains sodium 6mg
Inactive Ingredients
edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, 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
*Rugby Laboratories, Inc is not affiliated with the ower of the trademark Colace(r).
Rugby stool softener Laxative is distributed by Rugby Laboratories, Inc.
Mfd for: Rugby Laboratories, Inc
Duluth Georgia 30097
www.rugbylaboratories.com
Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880
* Please review the disclaimer below.
