KAO- TIN- docusate calcium capsule, liquid filled 
Major Pharmaceuticals

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.

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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

Major Pharmaceuticals Docusate calcium 240 mg

Docusate Calcium 240 mg

 

KAO- TIN 
docusate calcium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5779
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
CORN OIL (UNII: 8470G57WFM)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorRED (RED) Scoreno score
ShapeCAPSULE (OVAL) Size21mm
FlavorImprint Code P58
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5779-40500 in 1 BOTTLE; Type 0: Not a Combination Product12/01/201112/31/2020
2NDC:0904-5779-60100 in 1 BOTTLE; Type 0: Not a Combination Product12/01/201112/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33412/01/201112/31/2020
Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2018
 
Major Pharmaceuticals