Label: CHLORASEPTIC TOTAL SORE THROAT AND COUGH- menthol and benzocaine and dextromethorphan hydrobromide lozenge
- NDC Code(s): 67172-016-11
- Packager: Prestige Brands Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 6, 2024
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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)
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.
- a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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INGREDIENTS AND APPEARANCE
CHLORASEPTIC TOTAL SORE THROAT AND COUGH
menthol and benzocaine and dextromethorphan hydrobromide lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-016 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 mg BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 6 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg Inactive Ingredients Ingredient Name Strength 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 Color red Score no score Shape OVAL Size 4mm Flavor CHERRY Imprint Code C Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67172-016-11 1 in 1 CARTON 08/01/2010 1 15 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 08/01/2010 Labeler - Prestige Brands Holdings, Inc. (159655021)
