FDA Label for Kaopectate Peppermint Flavor Anti Diarrheal
View Indications, Usage & Precautions
- OTC - PURPOSE
- INDICATIONS & USAGE
- OTHER
- DO NOT TAKE IF YOU ARE
- DO NOT USE IF YOU HAVE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Kaopectate Peppermint Flavor Anti Diarrheal 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.
Otc - Purpose
| Active ingredient (per 15 mL) | Purposes |
| Bismuth subsalicylate 262 mg | Anti-diarrheal Upset stomach reliever |
Indications & Usage
Uses relieves
- traveler’s diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
Other
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.
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
Otc - Ask Doctor
Ask a doctor or pharmacist before use if you are taking any drug for
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
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
- 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 1/2 hour to 1 hour as needed.
- do not exceed 8 doses (240 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 15 mL dose cup contains: sodium 9 mg
- do not use if inner seal is broken or missing
- store at room temperature 20°-25° C (68°-77° F)
Inactive Ingredients
caramel, carboxymethylcellulose sodium, flavor, FD&C Red No. 40 microcrystalline cellulose, sodium salicylate, sorbic acid, sucrose, water, xanthan gum
Principal Display Panel
Kaopectate®
Bismuth Subsalicylate
• Anti-Diarrheal • Upset Stomach Reliever
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
8 fl oz (236 mL)
Peppermint Flavor
P993H11000
Peel
Kramer Laboratories, Inc.
Bridgewater, NJ 08807
1-800-824-4894
LOT EXP
P993H12000
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