Active Ingredient (In Each Softgel)
Docusate sodium 100 mg
Docusate Sodium
FDA Label NDC 69618-044
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable-1 Laboratories Llc for the product Docusate Sodium (NDC 69618-044). 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, otc - ask doctor, otc - ask doctor/pharmacist, 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
Purpose
Stool softener laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Warnings
Do not use if you are presently taking mineral oil, unless directed to do so by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
Otc - Ask Doctor/Pharmacist
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.
Otc - Stop Use
Stop use and ask a doctor if
- you have rectal bleeding or fail to have a bowel movement after use of a laxative.
- you need to use stool softner laxative for more than 1 week
These could be sings of a serious condition.
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
| adults and children 12 years and over | take 1 - 3 softgels once daily or in divded doses |
| children 2 to under 12 years of age | 1 softgel once daily |
| children under 2 years | ask a doctor |
Other Informaiton
- each softgel contains: s odium 7 mg
- store at room temperature 15°-25°C (59°-77°F) and avoid excessive heat
Inactive Ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol
Questions Or Comments?
Call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday
Other
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
*Reliabel-1 Laboratories LLC is not affiliated with the owner of the trademark Colace®
Distributed by: Reliable-1 Laboratories LLC Valley Stream, NY 11580
Made in Romania
Package Label.Principal Display Panel
NDC 69618-044-10
*Compare to the active ingredient in Colace®
Reliable-1 Laboratories
Docusate Sodium 100mg
STOOL SOFTENER LAXATIVE
1000 SOFTGELS
Label (2)
* Please review the disclaimer below.
