The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Docusate Sodium (NDC 69618-043). 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, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
*Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Colace®
Distributed by: Reliable-1 Laboratories LLC Valley Stream, NY 11580 www.reliable1labs.com
Docusate sodium 100 mg
Stool softener laxative
Do not use if you are presently taking mineral oil, unless directed to do so by a doctor
Ask a doctor before use if you have
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
If pregnant or breast-feeding, 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.
| adults and children 12 years and over | take 1 -3 softgels once daily or in divided doses | |
| children 2 to under 12 years of age | 1 softgel once daily | |
| children under 2 years | ask a doctor |
citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special and white edible ink
Call 516-341-066 8:30 am - 4:30 pm ET, Monday - Friday
NDC 69618-043-01
Docusate Sodium 100 mg 100 SOFTGELS
STOOL SOFTENER LAXATIVE
NDC 69618-043-10
Docusate Sodium 100 mg 1000 SOFTGELS
STOOL SOFTENER LAXATIVE
Bottle Label 1000ct (Re02 01)
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