KAO-TIN PEPPERMINT FLAVOR- bismuth subsalicylate liquid 
MAJOR Pharmaceuticals Inc.

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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maj kao-tin

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

1

KAO-TIN PEPPERMINT FLAVOR 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5709
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CARAMEL (UNII: T9D99G2B1R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
Product Characteristics
Colorred (brownish-red) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5709-09236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/201108/01/2019
2NDC:0904-5709-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/201108/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33502/14/201108/01/2019
Labeler - MAJOR Pharmaceuticals Inc. (191427277)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIBusiness Operations
GCP LABORATORIES965480861manufacture(0904-5709)

Revised: 11/2020
 
MAJOR Pharmaceuticals Inc.