Active Ingredients (In Each Lozenge)
Benzocaine 6 mg
Dextromethorphan HBr 5 mg
Menthol 10 mg
Cepastat Lozenge
FDA Label NDC 63736-205
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Cepastat (NDC 63736-205). 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 active ingredients (in each lozenge), purpose, uses, warnings, do not use, when using this product, stop use and ask a dentist or doctor if, 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
Purpose
Oral Anesthetic/Analgesic
Cough Suppressant
Oral Anesthetic/Analgesic
Uses
Temporarily relieves
- occasional minor irritation, pain, sore throat and sore mouth
- cough due to minor throat and bronchial irritation as may occur with the common cold
Warnings
Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.
Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor.
Do Not Use
- this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product.
- this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
When Using This Product
do not exceed recommended dosage.
Stop Use And Ask A Dentist Or Doctor If
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
- cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition.
Keep Out Of Reach Of Children.
In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children over 12 years of age: 2 lozenges every 4 hours – not to exceed 12 lozenges every 24 hours.
- Children 6-12 years of age: 1 lozenge every 4 hours – not to exceed 6 lozenges every 24 hours.
- Children under 6 years of age: consult a doctor.
Other Information
- Store between 59°F and 86°F (15°C - 30°C).
- Protect from moisture.
- Check expiration date before using.
Inactive Ingredients
acesulfame potassium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerine, hydrogenated starch hydrolysate, isomalt, soy lecithin, sucralose, water
Questions?
1-800-552-7932
Principal Display Panel
CĒPASTAT®
SORE THROAT & COUGH
Menthol/Benzocaine | Oral Anesthetic/Analgesic
Dextromethorphan HBr 5 mg | Cough Suppressant
FAST ACTING
SORE THROAT & COUGH RELIEF
18 LOZENGES
CHERRY
SUGAR FREE
Principal Display PanelcĒpastat® Sore Throat & Cough Menthol/benzocaine | Oral Anesthetic/analgesicdextromethorphan Hbr 5 mg | Cough Suppressantfast Actingsore Throat & Cough Relief18 Lozenges Cherrysugar Free (Cepastat Sore Throat And Cough 01)
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