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

DOK EXTRA STRENGTH STOOL SOFTENER

H.J. Harkins Company, Inc.
H.J. Harkins Company, Inc.

  • 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

Docusate Sodium 250mg

Stool softener

  • for the prevention of dry, hard stools
  • for relief of occasional constipation.
  • this product generally produces a bowel movement within 12 to 72 hours.
  • if you are 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

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

  • you have rectal bleeding
  • you fail to have a bowel movement after use

ask a health professional before use.

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

  • 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
  • each softgel contains sodium 15mg
  • store at controlled room temperature 15o - 30o C (59o- 86o F)
  • do not use if imprinted safety seal under cap is broken or missing

edible white ink, FD&C Red No# 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

Adverse Drug Event Call: (800) 616-2471

MAJOR DOK™

Docusate Sodium 250 mg

Extra Strength Stool Softener

For use as a Stool Softener in treating & Avoiding Constipation

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150, USA

Repacked by:

H.J. Harkins Company, Inc.

Grover Beach, CA 93433

 

Docusate Sodium 250 mg

DOK EXTRA STRENGTH STOOL SOFTENER

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76519-1003(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
POLYETHYLENE GLYCOLS
propylene glycol
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
ORANGE (orange) 20 mm P20 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76519-1003-6 60 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2002-08-27


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