KAOPECTATE- bismuth subsalicylate tablet, coated 
Kramer Laboratories

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 (per caplet)Purposes
Bismuth subsalicylate 262 mgAnti-diarrheal, Upset stomach reliever

Uses relieves:

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

Other information

Inactive ingredients

croscarmellose sodium, crospovidone, hydrated silica, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin

  

Principal Display Panel

FAST & EFFECTIVE RELIEF
Kaopectate
®
Bismuth Subsalicylate

• Anti-Diarrheal • Upset Stomach Reliver


Diarrhea & 
Upset Stomach


✓ Begins controlling symptoms from the first dose
✓ Quickly relieves urgency, gas, and cramping
✓ Effective on diarrhea from bacteria, viruses, and other causes

CLINICALLY PROVEN MEDICINE

28 Coated Caplets

Front Label Image

LOT

EXP

Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894

14711-07-20_K0720

Rear Label Image

Kaopectate®
Bismuth Subsalicylate

Diarrhea &  Upset Stomach

28 Coated Caplets

Do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.

KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION


Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894

14712-07-20_K0720

Bottle
KAOPECTATE 
bismuth subsalicylate tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-197
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bismuth Subsalicylate (UNII: 62TEY51RR1) (Bismuth Cation - UNII:ZS9CD1I8YE) Bismuth Subsalicylate262 mg
Inactive Ingredients
Ingredient NameStrength
Croscarmellose Sodium (UNII: M28OL1HH48)  
Crospovidone (UNII: 2S7830E561)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Mineral Oil (UNII: T5L8T28FGP)  
Povidone, Unspecified (UNII: FZ989GH94E)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Talc (UNII: 7SEV7J4R1U)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Triacetin (UNII: XHX3C3X673)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (caplet) Size17mm
FlavorImprint Code K
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55505-197-071 in 1 CARTON10/01/2020
128 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55505-197-701 in 1 CARTON02/01/2021
242 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33510/01/2020
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corporation057795122manufacture(55505-197)

Revised: 1/2021
Document Id: 20469e8e-fe4d-40f5-a3cf-7003ec2a03b2
Set id: 3877a88d-9546-48ce-ad6b-3c2a115e3eaf
Version: 2
Effective Time: 20210128
 
Kramer Laboratories