Kaopectate - Kramer Laboratories

Manufacturer
Kramer Laboratories
Effective date
2026-06-03
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-06-11 05:10:30

Label at a glance#

ProductKaopectate
Active ingredientBismuth Subsalicylate
Label structure7 sections

Dosage and administration

adults and children 12 years of age and older: 2 caplets (1 dose) swallow caplets with water; do not chew repeat dose every 1/2 hour to 1 hour as needed do not exceed 8 doses in 24 hours use until diarrhea stops but not more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

Uses relieves:

  • traveler’s diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • heartburn
    • indigestion
    • nausea
    • gas
    • belching
    • fullness


Warnings

WARNINGS SECTION

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

SPL UNCLASSIFIED SECTION

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Do not use if you have

OTC - DO NOT USE SECTION

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

OTC - WHEN USING SECTION

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older: 2 caplets (1 dose)
  • swallow caplets with water; do not chew
  • repeat dose every 1/2 hour to 1 hour as needed
  • do not exceed 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

SPL UNCLASSIFIED SECTION

  • Each caplet contains very low sodium
  • do not use if carton was opened or if printed foil inner seal under bottle cap is torn or missing
  • store at room temperature 20º-25º C (68º-77º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.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
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
Rear Label Image

Kaopectate®
Bismuth Subsalicylate

  • Anti-Diarrheal
  • Upset Stomach Reliever

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
Bottle

FAST & EFFECTIVE RELIEF

Kaopectate®
Bismuth Subsalicylate

  • Anti-Diarrheal
  • Upset Stomach Reliever

Diarrhea &
Upset Stomach


84 Coated Caplets

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


K0426

LOT:

EXP:

R55002

84ct front
84ct front

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

84ct rear
84ct rear

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix0071337-01bottle.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55505-19755505-197-07, 55505-197-70, 55505-197-78, 55505-197-77

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-12-19full-release2026-06-01 01:28:19

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KaopectateBISMUTH SUBSALICYLATEKramer Laboratories3877a88d-9546-48ce-ad6b-3c2a115e3eaf2026-06-03WarningsExact identifier
ndc (package): 55505-197-77
ndc (package): 55505-197-07
ndc (package): 55505-197-78
ndc (package): 55505-197-70
ndc (product): 55505-197
ndc11 (package): 55505019778
ndc11 (package): 55505019777
ndc11 (package): 55505019707
ndc11 (package): 55505019770
spl id: eb3ecda3-180e-4a04-9089-5cceabe22724
spl set id: 3877a88d-9546-48ce-ad6b-3c2a115e3eaf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.