CHLORASEPTIC TOTAL SORE THROAT AND COUGH, SUGAR FREE- menthol and benzocaine and dextromethorphan hydrobromide lozenge 
Prestige Brands Holdings, Inc.

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 Sugar Free Lozenges

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

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

Other Information

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

Chloraseptic® Total Sugar Free
SORE THROAT + COUGH Lozenges
Benzocaine / Menthol / Oral Anesthetic/Analgesic
Dextromethorphan HBr /Cough Suppressant
Wild Cherry|15 lozenges

CHLORASEPTIC TOTAL SORE THROAT AND COUGH, SUGAR FREE 
menthol and benzocaine and dextromethorphan hydrobromide lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorREDScore2 pieces
ShapeOVALSize4mm
FlavorCHERRYImprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67172-015-111 in 1 CARTON08/01/2010
115 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35608/01/2010
Labeler - Prestige Brands Holdings, Inc. (159655021)
Establishment
NameAddressID/FEIBusiness Operations
BestSweet, Inc.002149136MANUFACTURE(67172-015)

Revised: 5/2017
Document Id: df027ba7-4e38-42e6-931d-c79fd2fd6d34
Set id: 34e4234c-ed61-4795-99fe-d281cdb0af88
Version: 3
Effective Time: 20170503
 
Prestige Brands Holdings, Inc.