BRONCOLIN HONEY EUCALYPTUS- menthol lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

BRONCOLIN, S.A. de C.V.

INN (International Name):

MENTHOL

Composition:

MENTHOL 7.5 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Cough Suppressant/Oral Anesthetic temporarily relieves •Cough due to minor and bronchial irritation occurring with a cold or inhaled irritants •occasional minor irritation and sore throat •persistent or chronic cough such as occurs with smoking, asthma, or emphysema •cough accompanied by excessive phlegm (mucus) •cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. •sore throat is severe or irritation, pain, or redness lasts or worsens •sore mouth does not improve in 7 days.

Authorization status:

OTC monograph final

Summary of Product characteristics

BRONCOLIN HONEY EUCALYPTUS- MENTHOL LOZENGE
BRONCOLIN, S.A. DE C.V.
_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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CGHDRPMNTHLHNYEUCLYPTSBRNCLN
_ACTIVE INGREDIENT_
Menthol 7.5mg
_PURPOSE_
Cough Suppressant/Oral Anesthetic
_USES_
temporarily relieves •Cough due to minor and bronchial irritation
occurring with a cold or
inhaled irritants •occasional minor irritation and sore throat
_WARNINGS_
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. These symptoms may be serious.
ASK A DOCTOR BEFORE USE IF YOU HAVE
•persistent or chronic cough such as occurs with smoking, asthma, or
emphysema
•cough accompanied by excessive phlegm (mucus)
_WHEN USING THIS PRODUCT_
•do not exceed recommended dosage
STOP USE AND ASK A DOCTOR IF
•cough persists for more than 7 days, tends to recur, or is
accompanied by fever, rash,
or persistent headache. These could be signs of a serious condition.
•sore throat is
severe or irritation, pain, or redness lasts or worsens •sore mouth
does not improve in
7 days.
_KEEP OUT OF REACH OF CHILDREN_
IF PREGNANT OR BREAST FEEDING ask a Health Professional before using
_DIRECTIONS_
• adults and children 6 years and older: dissolve 1 drop slowly in
the mouth. May be
repeated every hour as needed or as directed by a doctor • children
under 6 years: ask
a doctor.
_INACTIVE INGREDIENTS_
Citric Acid, Elderberry flower extract, Eucalyptus leaf extract,
Eucalyptus oil leaf extract,
Glucose, Honey, Mullein flower extract, Sugar
PACKAGE LABEL
BRONCOLIN HONEY EUCALYPTUS
menthol lozenge
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:62583-002
BRONCOLIN, S.A. de C.V.
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH