Novex Sore Throat

Manufacturer
Herbion Pakistan (Pvt.) Ltd
Effective date
2020-04-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:37:50

Label at a glance#

ProductNovex Sore Throat
Active ingredientBENZOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredients (in each lozenge)

Benzocaine 15 mg

Menthol 3.6 mg

OTC - PURPOSE SECTION

Purposes 

Oral pain reliever

Oral pain reliever

INDICATIONS & USAGE SECTION

Uses
For the temporary relief of occasional

■ sore throat ■ sore mouth ■ minor irritation ■ pain

■ pain associated with canker sores

WARNINGS SECTION

Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
■ pale, gray, or blue colored skin (cyanosis)
■ headache
■ rapid heart rate
■ shortness of breath
■ dizziness or lightheadedness
■ fatigue or lack of energy


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: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor or dentist if


■ sore mouth symptoms do not improve in 7 days
■ irritation, pain, or redness persists or worsens
■ swelling, rash, or fever develops


If pregnant or breast-feeding, ask a health professional before use.

OTC - DO NOT USE SECTION

Do not use
■ for teething
■ in children under 5 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Do not exceed recommended dosage

DOSAGE & ADMINISTRATION SECTION

Directions
■ adults and children 5 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
■ children under 5 years of age: do not use

OTHER SAFETY INFORMATION

Other Information:

■ store at 20-25°C (68-77°F)
■
protect contents from humidity

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

FD&C red no. 40, Flavor, Isomalt, Maltitol, Sodium bicarbonate, Sucralose

OTC - QUESTIONS SECTION

Questions?

Call 1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm EST 

NDC 44237-045-05 NovexSore Throat Benzocaine 15mg, Menthol 3.6mg – Oral Pain Reliever √ Relieves Sore Throat Pain√ Maximum Numbing√ Fast Acting 1 lOZENGE every 2 HOURS 18 Lozenges Cherry Flavor *Based on amount of benzocaine per dose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Novex Sore Throat CherryNovex Sore Throat Cherry

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44237-04544237-045-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c1871746-5d7d-455e-ab45-2f16ee49481a4bf2f456-7a34-4b20-9138-b47f84603e092021-07-28WarningsExact identifier
spl set id: 4bf2f456-7a34-4b20-9138-b47f84603e09

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.