MIXED BERRY SORE THROAT LOZENGES- benzocaine lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)

Available from:

Topco Associates

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purposes Oral Pain Reliever Cough Suppressant Uses temporarily relieves these symptoms: - occasional minor mouth irritation, sore mouth and sore throat - cough due to minor throat and bronichial irritation as may occur with the common cold Do not use 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. - for teething - in children under 2 years of age Stop use and ask doctor if - sore mouth symptoms do not improve in 7 days - irritation, pain, or redness persists or worsens - swelling develops - cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

Authorization status:

OTC monograph not final

Summary of Product characteristics

MIXED BERRY SORE THROAT LOZENGES- BENZOCAINE LOZENGE
TOPCO ASSOCIATES
_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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BENZOCAINE 7.5 MG
DEXTROMETHORPHAN HYDROBROMIDE 5 MG
ACTIVE INGREDIENT (IN EACH LOZENGE)
Benzocaine 7.5 mg
Dextromethorphan hydrobromide 5 mg
PURPOSES
Oral Pain Reliever
Cough Suppressant
USES temporarily relieves these symptoms:
occasional minor mouth irritation, sore mouth and sore throat
cough due to minor throat and bronichial irritation as may occur with
the common
cold
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
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. If sore mouth symptoms do not improve in 7
days, or if
irritation, pain or redness persists or worsens, see your dentist or
doctor promptly.
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.
DO NOT USE 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 do not
know if your
prescription drug contains an MAOI, ask a doctor or pharmacist before
taking this
product.
for teething
in children under 2 years of age
ASK A DOCTOR BEF