Stool Softener description, usages, side effects, indications, overdosage, supplying and lots more!

Stool Softener

CVS Pharmacy

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 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.
 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

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

Principal Display Panel

Compare to the active ingredient in Colace® †

Stool Softener

Relieves Constipation

Docusate Sodium 100 mg

  • Gentle stool softener
  • Reliable relief

SOFTGELS

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2013 CVS/ Pharmacy

CVS.com 1-800-SHOP-CVS

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

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

Product Labeling

Product Labeling
Docusate Sodium 100 mg softgels

Stool Softener

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-038
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
D&C RED NO. 33
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
EGG PHOSPHOLIPIDS
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOLS
propylene glycol
water
SORBITAN
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 12 mm P10;S78;SCU2 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-038-01 100 in 1 BOTTLE
2 NDC:59779-038-03 30 in 1 BOTTLE
3 NDC:59779-038-25 250 in 1 BOTTLE
4 NDC:59779-038-36 36 in 1 BOTTLE
5 NDC:59779-038-40 400 in 1 BOTTLE
6 NDC:59779-038-75 750 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-07-30


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Be sure to consult your doctor before taking any medication!
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