STOOL SOFTENER description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

STOOL SOFTENER

TOP CARE (Topco Associates LLC)
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

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 stool softener 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.
 adults and children 12 years and over  take 1-3 softgels daily 
 children 2 to under 12 years of age  take 1 softgel daily 
 children under 2 years  ask a doctor

STOOL SOFTENER Other information

  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients

D&C Red #33, edible ink, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, and titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

SAFE, GENTLE & RELIABLE

Stool Softener

Docusate Sodium, 100 mg

Relieves Constipation

COMPARE TO COLACE® active ingreident*

SOFTGELS 100 mg EACH

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

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60007

topcare@topco.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

STOOL SOFTENER

Docusate Sodium 100 mg
 

STOOL SOFTENER

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-111
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 100 mg

Inactive Ingredients

Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
propylene glycol
sorbitol
D&C RED NO. 33
titanium dioxide
FD&C BLUE NO. 1
water
SORBITAN

Product Characteristics

Color Size Imprint Code Shape
WHITE 13 mm P10;51A OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:36800-111-01 100 in 1 BOTTLE
3 NDC:36800-111-25 250 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-07-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.