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

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Stool Softener

QUALITY CHOICE (Chain Drug Marketing Association)

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

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 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 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

D&C red #33*, D&C yellow #10*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin*, medium-chain triglycerides*, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in COLACE®

Stool Softener

Laxative

Docusate Sodium 100 mg

For Relief of:

Occasional Constipation

Softgels

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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

Product Labeling

Stool Softener
Quality Choice Stool Softener Softgel

Stool Softener

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63868-116
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
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
LECITHIN, SOYBEAN
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOLS
propylene glycol
water
SORBITAN
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 12 mm P10;S78;SCU2 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63868-116-01 100 in 1 BOTTLE, PLASTIC
2 NDC:63868-116-25 250 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-11-30


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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