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

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Stool Softener

EQUATE (Walmart Stores, Inc.)
P and L Development of New York Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Stool Softener Uses

  • relieves occasional constipation (irregularity)
  • generally produces a 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 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 of age  ask a doctor

Stool Softener Other information

  • 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, titanium dioxide.

Questions or comments?

1-888-287-1915

Principal Display Panel

Compare to the active ingredient in Colace® *    

Stool Softener

Docusate Sodium, 100 mg

  • Relieves constipation
  • Gentle and effective
  • Stimulant free for comfortable relief

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

Gluten free

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Satisfaction guaranteed- for questions or comments please call 1-888-287-1915

Product Labeling

Stool Softener
Docusate sodium 100 mg capsules

Stool Softener

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49035-111
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
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
propylene glycol
water
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 12 mm P10;51A OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:49035-111-06 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2012-03-01


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Be sure to consult your doctor before taking any medication!
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