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

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STOOL SOFTENER

CVS Pharmacy
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

  • for the prevention of dry, hard stools
  • for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

Warnings

Do not use

  • if you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea or vomiting are present
  • for longer than 1 week, unless directed by a doctor

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use

If pregnant or breast-feeding,

ask a health care 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 of age and over: take 1-3 softgels, preferably at bedtime
  • children 6 to 12 years of age: take 1 softgel at bedtime
  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15º-30ºC (59º-86ºF)

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

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to active ingredient in Phillips'® Stool Softener†

STOOL SOFTENER

DOCUSATE SODIUM 100 mg

  • Relieves constipation
  • Gentle, dependable relief

SOFTGELS

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2013 CVS/pharmacy

www.cvs.com   1-800-shop-CVS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Bayer Consumer Products, owner of the registered trademark Phillips'® Stool Softener.

 STOOL SOFTENER

CVS Stool Softener Two-Tone Softgel

STOOL SOFTENER

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-147
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 30 in 1 BOTTLE, PLASTIC
2 NDC:59779-147-30 1 in 1 BOX

Marketing Information

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


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