Otc - Purpose
| Active ingredient (per chew) | Purposes |
| Bismuth subsalicylate 262 mg | Anti-diarrheal, Upset stomach reliever |
Kaopectate Tablet, Chewable
FDA Label NDC 55505-206
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Kaopectate (NDC 55505-206). 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.
Label Section Quick Index
Indications & Usage
Uses relieves:
- traveler’s diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
Otc - When Using
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and older: 2 chews (1 dose)
- 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
- each soft chew contains: total salicylates 99 mg
- do not use if carton was opened or if printed foil inner seal under bottle cap is torn or missing
- store at room temperature 20°-25° C (68°-77° F)
Inactive Ingredients
calcium carbonate, confectioner’s sugar, corn syrup, corn syrup solids, FD&C red #40 aluminum lake, glycerin, hydrogenated coconut oil, natural masking flavor, soy lecithin, strawberry flavor, sucrose, water
Principal Display Panel
GREAT TASTE!
FAST & EFFECTIVE RELIEF
NEW!
Kaopectate®
Bismuth Subsalicylate • Anti-Diarrheal • Upset Stomach Reliever
Soft Chews
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
24 Soft Chews
Individually wrapped
Strawberry Flavor
Front Label Image (Front)
FAST & EFFECTIVE RELIEF
Do not take maximum dose for more than 2 days per week.
Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894
Rear Label Image (Back)
* Please review the disclaimer below.
