Active Ingredient (In Each Softgel)
Docusate Sodium 250mg
Dok Extra Strength Stool Softener
FDA Label NDC 0440-1466
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Liberty Pharmaceuticals, Inc. for the product Dok Extra Strength Stool Softener (NDC 0440-1466). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each softgel), purpose, uses, warnings - do not use, ask a doctor before use if, stop use and ask a doctor if, if pregnant or breastfeeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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
If Pregnant Or Breastfeeding
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 15o - 30o C (59o- 86o F)
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
edible white ink, FD&C Red No# 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.
Questions Or Comments?
Adverse Drug Event Call: (800) 616-2471
Product Labeling
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
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
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