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Stool Softener

P & L Development of New York Corporation

Sodium Free Stool Softener


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each softgel)

Docusate Calcium 240mg

Purpose

Stool softener

Stool Softener Uses

For relief of occasional constipation. This product generally produces a bowel movement within 12 to72 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 breastfeeding

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

  • adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor.
  • children under 12 years of age: take as directed by a doctor.

Stool Softener Other information

  • store at controlled room temperature 15 - 20 degrees C (59-86 degrees F)
  • do not use if imprinted safety seal under cap is broken or missing.
  • This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Surfak Stool Softener.

Inactive Ingredients

corn oil, DandC Red #33, edible white ink, FDandC Red #40, gelating, glycerin, purified water and sorbitol special.

Questions or comments?

call toll free: 1-877-753-3935

8Comapre to the active ingredient in Surfak Stool Softener                      NDC: 59726-170-01

Sodium Free

Stool Softener

Docusate Calcium 240mg

Gentle Relief of Constipation

100 softgels



Distributed by PL Development

Westbury, NY 11590 USA


Product Labeling

Stool Softener

Stool Softener

DOCUSATE CALCIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59726-170
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Docusate Calcium DOCUSATE 240 mg

Inactive Ingredients

Ingredient Name Strength
CORN OIL
D&C RED NO. 33
FD&C RED NO. 40
GELATIN
GLYCERIN
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
red (RED) 8 mm P58 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59726-170-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2011-12-01


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Be sure to consult your doctor before taking any medication!
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