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

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STOOL SOFTENER

Care One (American Sales Company)
P and L Development of New York Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Docusate Sodium 100 mg

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

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

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

ask a health care professional before use.

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

  • adults and children 12 years and over: take 1- 2 capsules preferably at bedtime
  • children 6 to 12 years of age: take 1 capsule at bedtime
  • each capsule contains: sodium 6 mg
  • store at controlled room temperature 15o - 30o C (59o- 86o F)
  • do not use if imprinted safety seal under cap is broken or missing.
  • *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®

D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and titanium dioxide. May also contain: FD&C blue #1 and purified water.

Principal Display Panel

Compare to active ingredient of COLACE®*

stool softener

Docusate sodium 100 mg

Distributed by: American Sales Company

4201 walden avenue, Lancaster, NY 14086

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:41520-115
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 25 in 1 BOTTLE
2 NDC:41520-115-10 100 in 1 BOTTLE
3 NDC:41520-115-20 250 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-07-20


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Be sure to consult your doctor before taking any medication!
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