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

Stool Softener

Good Sense (Geiss, Destin & Dunn, Inc.)
P and L Development of New York Corporation

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

  • temporary relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

  • if abdominal pain, nausea, or vomiting are present
  • 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 a 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 breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

  • take with a glass of water
 adults and children 12 years of age and over  take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
 children 2 to under 12 years of age  take 1 softgel daily
 children under 2 years of age  ask a doctor

Other information

  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special

Questions or comments?

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

Principal Display Panel

Gentle Stool Softener

Docusate Sodium

For Gentle, Softening Relief

Gluten Free

Softgels (100 mg Each) 

*Compare to active ingredient in Dulcolax® Stool Softener

*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare, owner of the registered trademark of Dulcolax®.

Distributed by: Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels.com

Product of USA

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Product Label
Good Sense Stool Softener Orange Softgel

Stool Softener

DOCUSATE SODIUM CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50804-005
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
POLYETHYLENE GLYCOLS
propylene glycol
water
sorbitol
SORBITAN

Product Characteristics

Color Size Imprint Code Shape
ORANGE 13 mm P51 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 25 in 1 BOTTLE, PLASTIC
2 NDC:50804-005-25 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-08-24


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Be sure to consult your doctor before taking any medication!
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