HERBION NATURALS MINT COUGH DROPS SUGAR FREE- 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 in 2.5

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Cough suppressant / Oral Anesthetic Uses: - 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 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

Authorization status:

OTC monograph final

Summary of Product characteristics

HERBION NATURALS MINT COUGH DROPS SUGAR FREE- 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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ACTIVE INGREDIENT (IN EACH DROP):
Menthol, 5.5mg
PURPOS E:
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
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:
store in a cool, dry place, below 77°F
protect from heat and light
INACTIVE INGREDIENTS:
Ascorbic Acid, Natural mint flavor, Stevia , Citric acid, Eucalyptus
oil, Greater galangal Rhizome,
Hyssop, Large-leaf geiger tree Fruit, Licorice Root, Isomalt , Long
pepper Fruit, Malabar nut tree Leaf
QUESTIONS OR COMMENTS?
1-888-(OK-HERBION) 654-3724, Monday through Friday 9am - 5pm EST
HERBION NATURALS MINT COUGH DROPS SUGAR FREE
menthol lozenge
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:44237-0 28
ROUTE OF ADMINISTRATION
ORAL
ACTIV