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Natural Product Number (NPN):

80127470

Market status:

Not Marketed

Licence Status:

Active

Brand name(s):

Benzocaine 7.5mg + Menthol 2.6mg Throat Lozenges ;
Pain Relief Lozenges Regular Strength

Licence holder:

CellChem Pharmaceuticals Inc.

Dosage Form:

Lozenge

Recommended route of administration:

Oral

Recommended use or purpose:

For temporary relief of pain of (minor) sore throat. For the temporary relief of (minor) sore throat. For the temporary relief of coughs. Helps ease/relieve nasal congestion. Makes nasal passages feel clearer.

Risk Information:

Cautions and Warnings 

Keep out of reach of children. In case of overdose, call a poison control centre or get medical help right away. Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care professional if cough worsens and persists for more than 7 days, or is accompanied by a fever. Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care professional if sore throat is severe, persists for more than two days, or is accompanied by or followed by other symptoms such as fever, headache, rash, swelling, nausea, or vomiting, consult a health care practitioner promptly. Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care professional if sore throat symptoms worsen or persist for more than 2 days.

Contra-Indications 

Do not use if allergic to benzocaine.

Known Adverse Reactions 

Allergy alert: Hypersensitivity/allergy is known to occur. In such a case, discontinue use. / Allergy alert: Stop use if hypersensitivity/allergy occurs.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
4-Aminobenzoic acid, ethyl ester	7.5 mg
dl-Menthol	2.6 mg

List of non-medicinal ingredients:

• Cherry flavour
• FD&C Red No. 3
• Isomalt
• Methylparaben
• Ponceau 4R
• Propylparaben
• Sucralose

Date of licensing:

2023-10-19

Revised date of licence: