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Chloraseptic Sore Throat Lozenge

Generic Name: menthol, benzocaine and dextromethorphan hydrobromide
Dosage Form: lozenge

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:67172-016-11 1 BLISTER PACK (1 BLISTER) in 1 CARTON
1 15 LOZENGE (15 LOZENGE) in 1 BLISTER PACK
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: 11/2010
 
Prestige Brands Holdings, Inc.



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