Docusate Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

Docusate Sodium

NCS HealthCare of KY, Inc dba Vangard Labs

  • 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
Docusate Sodium 250mg

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Docusate Sodium 250mg

Purpose

Stool Softener

Uses

• for the prevention of dry, hard stools.

• for relief of occasional constipation

• this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

• if you are currently taking mineral oil, unless directed by a doctor

• when abdominal pain, nausea, or vomiting are present

• for more than 1 week, unless directed by a doctor

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding

• you fail to have a bowel movement after use

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

• adults and children over 12 years of age and over: take 1 softgel daily or as directed by a doctor

• children under 12 years of age: take as directed by a doctor

Other information

• each softgel contains: sodium 15mg

• store at controlled room temperature 15° - 30° C (59° - 86° F)

• do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

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

Adverse Drug Event Call: (800) 616-2471

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150, USA

Principal Display Panel

Docusate Sodium Softgel Caps 250mg

Principal Display Panel

Docusate Sodium

Docusate Sodium CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0615-0586(NDC:0904-7891)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 250 mg

Inactive Ingredients

Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
propylene glycol
water
sorbitol
POLYETHYLENE GLYCOLS

Product Characteristics

Color Size Imprint Code Shape
RED (Orange) 21 mm P20 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-0586-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-07-01


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Be sure to consult your doctor before taking any medication!
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