Stool Softener description, usages, side effects, indications, overdosage, supplying and lots more!

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Stool Softener

Freds Inc
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 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 does or in divided doses.
 adults and children 12 years and over   take 1 to 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

Docusate Sodium 100 mg

Compare to the active ingredient in: Colace®*    

Softgels 

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN 38118

www.fredsinc.com

Product Labeling

Stool Softener
Fred's Stool Softener two-tone Softgel

Stool Softener

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55315-110
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
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
propylene glycol
water
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm P10;51A OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55315-110-01 100 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-03-01


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Be sure to consult your doctor before taking any medication!
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