Docusate Sodium 100 mg
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each softgel)
Docusate sodium 100 mg
OTC - PURPOSE SECTION
Purpose
Stool softener laxative
INDICATIONS & USAGE SECTION
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use if you are presently taking mineral oil, unless directed to do so by a doctor
OTC - ASK DOCTOR SECTION
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 SECTION
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 SECTION
Stop use and ask a doctor if
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
- you need to use stool softner laxative for more than 1 week
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 |
STORAGE AND HANDLING SECTION
Other information
- each softgel contains: s odium 7 mg
- store at room temperature 15º-25ºC (59º-77ºF) and avoid excessive heat
INACTIVE INGREDIENT SECTION
Inactive ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol
OTC - QUESTIONS SECTION
Questions or comments? Call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday
SPL UNCLASSIFIED SECTION
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
Made in Romania
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 69618-044-10
*Compare to the active ingredient in Colace®
Reliable-1™ LABORATORIES
Docusate Sodium 100 mg
STOOL SOFTENER LAXATIVE
1000 SOFTGELS