KAO-TIN PEPPERMINT FLAVOR

Dosage form: liquid
Ingredients: BISMUTH SUBSALICYLATE 262mg in 15mL
Labeler: MAJOR Pharmaceuticals Inc.
NDC Code: 0904-5709

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.

Active ingredient (in each 15 mL Tbsp)Bismuth subsalicylate 262 mg

Purposes

antidiarrheal
upset stomach reliever

Uses
  • relieves diarrhea
  • relieves upset stomach and nausea associated with it

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert:Contains salicylate. Do not take if you are

  • allergic to salicylates (including aspirin)
  • taking other salicylate products
Do not use if you have
  • an ulcer
  • a bleeding problem
  • bloody or black stool
Ask a doctor before use if you have
  • fever
  • mucus in the stool
Ask a doctor or pharmacist before use if you are taking any drug for
  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
Stop use and ask a doctor if
  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days
If pregnant or breast-feeding, 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
  •  shake well before using
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
adults and children 12 years and over
  • take 2 tablespoonfuls (Tbsp)
  • repeat dose every 1/2 hour to 1 hour as needed
  • do not exceed 8 doses (16 Tbsp or 240 mL) in 24 hours
  • use until diarrhea stops but not more than 2 days
children under 12 years: ask a doctor

Other information
  • each 15 mL tablespoon contains: salicylate 130 mg, sodium 10 mg
  • protect from freezing
  • avoid excessive heat (over 104F or 40C)
  •  TAMPER-EVIDENT: Do not use this product if foil seal under the cap is broken or punctured.
  • visit www.info-xtra.com for health information

Inactive ingredients

caramel, carboxymethylcellulose sodium, FD and C red no. 40, flavor, microcrystalline cellulose, purified water, sodium salicylate, sorbic acid, sucrose, titanium dioxide, xanthan gum

package Label

NDC 00904-5709-09  

MAJOR

effective diarrhea relief

Kao-Tin

bismuth subsalicylate 262mg
  • anti-diarrheal
  • upset stomach reliever
PEPPERMINT FLAVOR
compare to the active ingredient of Kaopectate Peppermint flavor
*this product is not manufactured or distributed by the owner of the registered trademark Kaopectate Peppermint flavor.

8 FL OZ (236 mL)


KAO-TIN PEPPERMINT FLAVOR 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5709
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH SUBSALICYLATE) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CARAMEL 
CARBOXYMETHYLCELLULOSE SODIUM 
FD&C RED NO. 40 
CELLULOSE, MICROCRYSTALLINE 
WATER 
SODIUM SALICYLATE 
SORBIC ACID 
SUCROSE 
TITANIUM DIOXIDE 
XANTHAN GUM 
PEPPERMINT OIL 
Product Characteristics
Colorred (brownish-red) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5709-09236 mL in 1 BOTTLE
2NDC:0904-5709-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33502/14/2011
Labeler - MAJOR Pharmaceuticals Inc. (191427277)
Registrant - GCP Laboratories (965480861)

Revised: 07/2012
 
MAJOR Pharmaceuticals Inc.

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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