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Stool Softener

P & L Development of New York Corporation

Gentle Relief Stool Softener


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients (in each softgel)

Docusate Sodium 100mg

Purpose

Stool softener

Stool Softener Uses

  • temporary relief of occasional constipation.
  • This product generally produces a bowel movement within 12 to72 hours.

Warnings - Do not use


Ask a doctor before use if

  • you notice a sudden change in bowel habits that persists over a period of 2 weeks.
  • you are presently taking mineral oil

Stop use and ask a doctor if

  • rectal bleeding or failure to have bowel movement occur after use which may indicate a serious condition
  • you need to use a laxative for more than 1 week.

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 immediately.

Directions

  • adults and children over 12 years of age: take 1 to 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 6mg
  • store at controlled room temperature 15 - 30 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 Boehringer Ingelheim Consumer Healthcare, owner of the registered trademark Dulcolax.

Inactive Ingredients

edible ink, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene, propylene glycol, purified water and sorbitol special.

Questions or comments?

call toll free: 1-877-753-3935

Comapre to the active ingredient in Dulcolax Stool Softener                      NDC: 59726-005-25

Gentle Relief

Stool Softener

Docusate Sodium 100mg

Fast, Dependable Relief of Occasional Constipation

25 softgels



Distributed by PL Development

Westbury, NY 11590 USA


Product Labeling

Stool Softener

Stool Softener

Stool Softener

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59726-005
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
HIGH DENSITY POLYETHYLENE
propylene glycol
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
orange (ORANGE) 8 mm P51 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 25 in 1 BOTTLE
2 NDC:59726-005-25 1 in 1 BOX

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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