FDA Label for Docusate Sodium
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH SOFTGEL)
- PURPOSE
- USES
- WARNINGS
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS ?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Reliable 1 Laboratories Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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
Active Ingredient (In Each Softgel)
Docusate sodium 100 mg
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 bowel movement after use of a laxative. These could be sings of a serious condition.
- you need to use a stool softener laxative for more than 1 week
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 divided doses | |
children 2 to under 12 years of age | 1 softgel once daily | |
children under 2 years | ask a doctor |
Other Safety Information
- each softgel contains: sodium 5 mg
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
Inactive Ingredients
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
Questions Or Comments ?
Call 516-341-066 8:30 am - 4:30 pm ET, Monday - Friday
Package Label.Principal Display Panel
NDC 69618-043-10
Docusate Sodium 100 mg
STOOL SOFTENER
LAXATIVE
1000 SOFTGELS
* Please review the disclaimer below.