Chloraseptic Sore Throat Lozenge

Dosage Form: lozenge
Chloraseptic Total Wild Cherry Lozenge

Drug Facts

Active Ingredients

(in each lozenge)

Benzocaine 6 mg

Purpose

Oral Anesthetic/Analgesic

Active Ingredients

(in each lozenge)

Dextromethorphan HBr 5 mg

Purpose

Cough Suppressant

Active Ingredients

(in each lozenge)

Menthol 10 mg

Purpose

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.

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 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 59ºF and 86ºF (15ºC - 30ºC).
  


• Protect from moisture.
  


• Tamper Evident: Do not use if blister package with “Chloraseptic®” name has been disturbed or opened.
  


• Check expiration date before using.

Inactive Ingredients

Corn Syrup, FD&C Blue #1, FD&C Red #40, Flavor, Glycerine, Soy Lecithin, Sucrose, Water

Questions?

1-800-552-7932 or www.chloraseptic.com

PRINCIPAL DISPLAY PANEL

Chloraseptic® Total

SORE THROAT + COUGH FAST ACTING RELIEF

15 lozenges | Wild Cherry

CHLORASEPTIC SORE THROAT LIQUID CENTER  menthol and benzocaine and dextromethorphan hydrobromide  lozenge

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 67172-016 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 10 mg BENZOCAINE (BENZOCAINE) BENZOCAINE 6 mg DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 5 mg

Inactive Ingredients Ingredient Name Strength CORN SYRUP   FD&C BLUE NO. 1   FD&C RED NO. 40   GLYCERIN   LECITHIN, SOYBEAN   SUCROSE   WATER

Product Characteristics Color RED Score 2 pieces Shape OVAL Size 4mm Flavor CHERRY Imprint Code C Contains

Packaging # NDC Package Description Multilevel Packaging 1 67172-016-11 1 BLISTER In 1 CARTON contains a BLISTER PACK 1 15 LOZENGE In 1 BLISTER PACK This package is contained within the CARTON (67172-016-11)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part356	08/01/2010

Labeler - Prestige Brands Holdings, Inc. (159655021)

Establishment
Name	Address	ID/FEI	Operations
BestSweet, Inc.		002149136	MANUFACTURE

Revised: 11/2010Prestige Brands Holdings, Inc.