FDA Label for Kaopectate
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (PER 15 ML)
- PURPOSES
- USES
- WARNINGS
- DO NOT TAKE IF YOU ARE
- DO NOT USE IF YOU HAVE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Kaopectate Product Label
The following document was submitted to the FDA by the labeler of this product Kramer Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (Per 15 Ml)
Bismuth subsalicylate 525 mg
Purposes
Anti-diarrheal
Upset stomach reliever
Uses
relieves:
- traveler's diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
including:
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
- a sodium-restricted diet
- fever
- mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are
taking any drug for
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
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 immediately before each use
- only use pre-measured dose cup
- adults and children 12 years of age and older: 1 dose (30 mL) every hour as needed.
- do not exceed 4 doses (120 mL) 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 30 mL dose cup contains: sodium 13 mg and salicylate 507 mg
- store at room temperature 20°-25° C (68°-77° F)
Inactive Ingredients
caramel, carboxymethylcellulose sodium, FD&C Red No. 40, flavor, microcrystalline cellulose, sodium salicylate, sorbic acid, sucrose, water, xanthan gum
Principal Display Panel
EXTRA
STRENGTH
2X
THE MEDICINE
PER DOSE
Kaopectate®
Bismuth Subsalicylate 525 mg
● Anti-Diarrheal ● Upset stomach Reliever
Diarrhea &
Upset Stomach
√ Begins controlling symptoms from the first dose
√ Twice the medicine as regular strength Kaopectate
√ Quickly relieves urgency, gas, and cramping
11 fl oz (325 mL)
Peppermint Flavor
682PPT11KA0LB
DO NOT USE IF INNER SEAL IS BROKEN OR MISSING
Kramer Laboratories, Bridgewater, NJ 08807 1-800-824-4894
K0825 682PPT11KA0LB
Lot:
Exp:
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