Label: KAO- TIN- docusate calcium capsule, liquid filled
- NDC Code(s): 0904-5779-40, 0904-5779-60
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated December 20, 2018
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- Active Ingredient (in each softgel)
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.
- Other information
- Inactive Ingredients
- Questions ?
PRINCIPAL DISPLAY PANEL
MAJOR KAO- TIN ™
Docusate Calcium 240 mg
For Mild, Dependable, More natural relief of constipation
Non- habit forming
*Compare to the active ingredient in Surfak® Stool Softener
31778 Enterprise Drive
Livonia MI 48150 USA
- Product Label
INGREDIENTS AND APPEARANCE
docusate calcium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5779 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM 240 mg Inactive Ingredients Ingredient Name Strength 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 Color RED (RED) Score no score Shape CAPSULE (OVAL) Size 21mm Flavor Imprint Code P58 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-5779-40 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2011 12/31/2020 2 NDC:0904-5779-60 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2011 12/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 12/01/2011 12/31/2020 Labeler - Major Pharmaceuticals (191427277)