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Chloraseptic Sore Throat Lozenge: Package Insert / Prescribing Info

Package insert / product label
Generic name: menthol, benzocaine and dextromethorphan hydrobromide
Dosage form: 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

Indications and Usage for Chloraseptic Sore Throat Lozenge

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.

Ask a doctor before use if you have

  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a cough is 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.

Chloraseptic Sore Throat Lozenge Dosage and Administration

  • 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.
  • Check expiration date before using.

Inactive ingredients

Corn Syrup, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Glycerin, Soy Lecithin, Sucrose, Water

Questions?

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

PRINCIPAL DISPLAY PANEL

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

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

CHLORASEPTIC TOTAL SORE THROAT AND COUGH
menthol and benzocaine and dextromethorphan hydrobromide lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67172-016
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
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
Product Characteristics
ColorREDScoreno score
ShapeOVALSize4mm
FlavorCHERRYImprint CodeC
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67172-016-111 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(67172-016)