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

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STOOL SOFTENER

BJWC (Berkley & Jensen / BJ's)
P and L Development of New York Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Docusate Sodium 100 mg

Stool softener

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours.
  • if you are presently taking mineral oil, unless told to do so by a doctor
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
  • 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

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

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

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?

Call toll free: 1-800-934-1204 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient of COLACE®*

stool softener

Docusate sodium, 100 mg

Convenient & Predictable relief of constipation

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®

STOOL SOFTENER
Docusate Sodium 100 mg

STOOL SOFTENER

DOCUSATE SODIUM CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68391-110
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

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 NDC:68391-110-04 400 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-06-10


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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