Topcare Sore Throat Cherry Flavor
FDA Label NDC 36800-813
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Sore Throat Cherry Flavor (NDC 36800-813). 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 topcare sore throat cherry flavor, otc - purpose, uses, otc - do not use, other, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each lozenge) | Purpose |
|---|---|
| Benzocaine 15 mg | Oral anesthetic |
| Menthol 3.6 mg | Oral anesthetic |
Uses
temporarily relieves these symptoms:
- occasional minor irritation, pain, sore mouth and sore throat
- pain associated with canker sores
Otc - Do Not Use
Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or any other "caine" anesthetics.
Other
Sore throat warning:
Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, nausea, and vomiting may be serious. Consult a dentist or doctor right away. Do not use more than 2 days or administer to children under 5 years of age unless directed by a doctor.
Stop Use And Ask A Doctor If
- sore throat is severe or irritation, pain or redness persists or worsens
- sore mouth symptom do not improve in 7 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 this and all drugs out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
adults and children 5 years of age and older: allow 1 lozenge to dissolve slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist.
children under 5 years: ask a doctor
Other Information
- store at room temperature
- protect from moisture
Inactive Ingredients
FD C Red 40, glucose syrup, N A Flavoring, propylene glycol, sucrose, and water. Soybean oil and corn starch used as processing aids.
Questions Or Comments?
1-888-423-0139
Topcare Sore Throat Lozenges Cherry Flavor 18 Count (36800-813-18)
TopCare
FAST-ACTING RELIEF
Sore Throat
Lozenges
MENTHOL • BENZOCAINE
ORAL ANESTHETIC
• Fast, soothing, temporary
relief of minor sore throat
pain and Irritation
Cherry Flavor
COMPARE TO CEPACOL
active ingredients
18 LOZENGES
DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
1-888-423-0139 ©TOPCO BSS3114
This product is not manufactured or distributed
by Reckftt Bencldser owner af the registered
trademark Cepacol.
Topcarecherryflavor (Topcarecherryflavor)
* Please review the disclaimer below.
