Otc - Purpose
| Active ingredient (per caplet) | Purposes |
| Bismuth subsalicylate 262 mg | Anti-diarrheal, Upset stomach reliever |
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Kaopectate (NDC 55505-197). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - purpose, indications & usage, warnings, do not take if you are, do not use if you have, ask a doctor before use if you have, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
| Active ingredient (per caplet) | Purposes |
| Bismuth subsalicylate 262 mg | Anti-diarrheal, Upset stomach reliever |
Uses relieves:
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.
Ask a doctor or pharmacist before use if you are taking any drug for
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
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.
croscarmellose sodium, crospovidone, hydrated silica, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin
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
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
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
* Please review the disclaimer below.