KAO- TIN

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE CALCIUM 240mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-5779

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

Active Ingredient (in each softgel)

Docusate Calcium 240mg

Purpose

Stool softener

Uses

For relief of occasional constipation. This product generally produces a bowel movement within 12 to72 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 longer 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: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor.
  • children under 12 years of age: take as directed by a doctor.

Other information
  • store at controlled room temperature 15o - 30o C (59o- 86o F)
  • do not use if imprinted safety seal under cap is broken or missing.
  • *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Surfak® Stool Softener.

Inactive Ingredients

corn oil, DandC Red #33, edible white ink, FD&C Red #40, gelatin, glycerin, purified water and sorbitol special.

Questions ?

Adverse Drug Event Call: (800) 616-2471

NDC 0904-5779-60

MAJOR KAO- TIN ™

Docusate Calcium 240 mg

Stool Softener

For Mild, Dependable, More natural relief of constipation

Non- habit forming

NO SODIUM

*Compare to the active ingredient in Surfak® Stool Softener         

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia MI 48150 USA

Product Label

Docusate Calcium 240 mg

 

KAO- TIN 
docusate calcium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5779
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (DOCUSATE) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
CORN OIL 
D&C RED NO. 33 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
WATER 
SORBITOL 
Product Characteristics
ColorRED (RED) Scoreno score
ShapeCAPSULE (OVAL) Size21mm
FlavorImprint CodeP58
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5779-40500 CAPSULE, LIQUID FILLED (500 CAPSULE) in 1 BOTTLE
2NDC:0904-5779-60100 CAPSULE, LIQUID FILLED (100 CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33412/01/2011
Labeler - Major Pharmaceuticals (191427277)

Revised: 08/2012
 
Major Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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