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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)

Available from:

Herbion Pakistan (Pvt.) Ltd

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purposes  Oral pain reliever Oral pain reliever Uses For the temporary relief of occasional ■ sore throat ■ sore mouth ■ minor irritation ■ pain ■ pain associated with canker sores Do not use ■ for teething ■ in children under 5 years of age

Authorization status:

OTC monograph not final

Summary of Product characteristics

NOVEX SORE THROAT HONEY LEMON FLAVOR- BENZOCAINE AND MENTHOL,
UNSPECIFIED
FORM LOZENGE
HERBION PAKISTAN (PVT.) LTD
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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DRUG FACTS
ACTIVE INGREDIENTS (IN EACH LOZENGE)
Benzocaine 15mg
Menthol 3.6mg
PURPOSES
Oral pain reliever
Oral pain reliever
USES
For the temporary relief of occasional
■ sore throat ■ sore mouth ■ minor irritation ■ pain
■ pain associated with canker sores
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.
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
■ for teething
■ in children under 5 years of age
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
DIRECTIONS
■ adults and children 5 years of age and older: allow one lozenge to
dissolve slowly in the mouth; may
be repeated every