Chloraseptic Total Sore Throat And Cough, Sugar Free Lozenge
FDA Label NDC 67172-015

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prestige Brands Holdings, Inc. for the product Chloraseptic Total Sore Throat And Cough, Sugar Free (NDC 67172-015). 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, purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a dentist or doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

(in each lozenge)

Benzocaine 6 mg

(in each lozenge)

Dextromethorphan HBr 5 mg

(in each lozenge)

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.

Ask A Doctor Before Use If You Have

  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a cough accompanied by excessive phlegm (mucus)

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.

If Pregnant Or Breast-Feeding,

ask a health care professional before use.

Keep Out Of Reach Of Children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center (1-800-222-1222) 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 Chloraseptic.com

Principal Display Panel

Chloraseptic® Total Sugar Free
SORE THROAT + COUGH Lozenges
Benzocaine / Menthol / Oral Anesthetic/Analgesic

Dextromethorphan HBr /Cough Suppressant

Wild Cherry|15 lozenges

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Chloraseptic® Total Sugar Freesore Throat + Cough Lozengesbenzocaine / Menthol / Oral Anesthetic/analgesicdextromethorphan Hbr /cough Suppressantwild Cherry|15 Lozenges (Chloraseptic Sugar Free Lozenges 01)

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