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

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STOOL SOFTENER

Preferred Plus (Kinray)
P and L Development of New York Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

STOOL SOFTENER Uses

  • relieves occasional constipation (irregularity)
  • generally produces 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 laxative 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  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 and titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Stool Softener

*Compare to the Active Ingredient in COLACE®

Each softgel contains 100 mg Docusate Sodium

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®.

Distributed by: Kinray, Inc.

152-35 Tenth Avenue

Whitestone, NY 11357

Product Label

STOOL SOFTENER

Preferred Plus Stool Softener TT Softgel
 

STOOL SOFTENER

DOCUSATE SODIUM CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61715-035
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
SORBITAN

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 NDC:61715-035-57 250 in 1 BOTTLE, PLASTIC
2 NDC:61715-035-99 1000 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-07-13


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Be sure to consult your doctor before taking any medication!
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