NOVEX SORE THROAT HONEY LEMON FLAVOR- benzocaine and menthol, unspecified form lozenge

Novex Sore Throat Honey Lemon Flavor by

Drug Labeling and Warnings

Novex Sore Throat Honey Lemon Flavor by is a Otc medication manufactured, distributed, or labeled by Herbion Pakistan (Pvt.) Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients (in each lozenge)

Benzocaine 15mg

Menthol 3.6mg

PURPOSE

Purposes 

Oral pain reliever

Oral pain reliever

INDICATIONS & USAGE

Uses
For the temporary relief of occasional

■ sore throat ■ sore mouth ■ minor irritation ■ pain

■ pain associated with canker sores

WARNINGS

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.

ASK DOCTOR

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.

DO NOT USE

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

KEEP OUT OF REACH OF CHILDREN

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

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

Inactive Ingredients:

Caramel, FD&C Yellow no. 6, Flavors, Isomalt, Maltitol, Sodium Bicarbonate, Sucralose

QUESTIONS

Questions?

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

NDC:

44237-046-05 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 Honey Lemon Flavor *Based on amount of benzocaine per dose

INGREDIENTS AND APPEARANCE

NOVEX SORE THROAT HONEY LEMON FLAVOR 
benzocaine and menthol, unspecified form lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44237-046
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	15 mg  in 2.5
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	3.6 mg  in 2.5

Inactive Ingredients
Ingredient Name	Strength
ISOMALT (UNII: S870P55O2W)
MALTITOL (UNII: D65DG142WK)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CARAMEL (UNII: T9D99G2B1R)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	17mm
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44237-046-05	2 in 1 CARTON	04/03/2020
1		9 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 not final	part356	04/03/2020

Labeler - Herbion Pakistan (Pvt.) Ltd (645482936)

Registrant - Herbion Pakistan (Pvt.) Ltd (645482936)

Establishment
Name	Address	ID/FEI	Business Operations
Herbion Pakistan (Pvt.) Ltd		645482936	manufacture(44237-046)