Stool Softener

TOP CARE (Topco Associates LLC)

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each softgel)
• Purpose
• Stool Softener Uses
• Warnings
  • Do not use
  • Ask a doctor before use if you have
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children.
• Directions
• Stool Softener Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel
• Product Labeling

FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Stool Softener 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 told to do so by a 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

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 a laxative for more than 1 week

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.

Directions

• take only by mouth. Doses may be taken as a single daily dose or in divided doses.

Stool Softener Other information

• each softgel contains: sodium 6 mg
• store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

D&C red #33*, D&C yellow #10*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin*, medium-chain triglycerides*, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

GENTLE & EFFECTIVE

Stool Softener

LAXATIVE

DOCUSATE SODIUM 100 mg

• Stimulant-Free For Comfortable Relief

COMPARE TO COLACE® active ingredient†

SOFTGELS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Labeling