FDA Label for Cepastat Sore Throat And Cough
View Indications, Usage & Precautions
Cepastat Sore Throat And Cough Product Label
The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals Llc. 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 Ingredients (In Each Lozenge)
Benzocaine 6 mg
Dextromethorphan HBr 5 mg
Menthol 10 mg
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
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