HERBION NATURALS HONEY LEMON- menthol lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Herbion Pakistan (Pvt.) Ltd

INN (International Name):

MENTHOL

Composition:

MENTHOL 5.5 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold - for temporary relief of occasional minor irritation, pain, sore mouth and sore throat - persistent or chronic cough such as occurs with smoking, asthma or emphysema - cough that is accompanied by excessive phlegm (mucus) - cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition - sore mouth does not improve in 7 days - irritation, pain or redness persists or worsens

Authorization status:

OTC monograph final

Summary of Product characteristics

HERBION NATURALS HONEY LEMON - MENTHOL 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 INGREDIENT (IN EACH DROP):
Menthol, 5.5mg
PURPOS E
Menthol, 5.5mg.........................Cough Suppressant / Oral
Anesthetic
US ES
temporarily relieves cough due to minor throat and bronchial
irritation associated with the common
cold
for temporary relief of occasional minor irritation, pain, sore mouth
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, nausea or vomiting, consult a
doctor promptly. These may be
serious.
ASK A DOCTOR BEFORE USE IF YOU HAVE
persistent or chronic cough such as occurs with smoking, asthma or
emphysema
cough that is accompanied by excessive phlegm (mucus)
STOP USE AND ASK A DOCTOR IF
cough persists for more than 1 week, tends to recur, or is accompanied
by fever, rash, or persistent
headache. These could be signs of a serious condition
sore mouth does not improve in 7 days
irritation, pain or redness persists or worsens
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
adults and children 2 years of age and over: Dissolve 1 drop slowly in
mouth. Repeat every 2 hours
as needed or as directed by a doctor
children under 2 years of age: consult a physician
OTHER INFORMATION
diabetic patients should not use Herbion drops without the advice of a
physician and they should
monitor glucose levels closely while taking drops as they may alter
blood-glucose levels
store in a cool, dry place, below 77°F
protect from heat and light
INACTIVE INGREDIENTS
Ascorbic Acid, Artificial Honey Flavor, Artificial Lemon Flavor,
Artificial Mint Flavor, Artificial
Yellow Color, Artificial Brown Color, Cane Sugar, Citric Acid,
Eucalyptus Oil, Greater Galangal
Rhizome, Hyssop, Large-leaf Geiger Tree Fruit, Li