MENTHOL COUGH DROPS- menthol lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

CVS Pharmacy

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Cough suppressant / Oral anesthetic Uses temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat Stop use and ask 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

Authorization status:

OTC monograph final

Summary of Product characteristics

MENTHOL COUGH DROPS- MENTHOL LOZENGE
CVS PHARMACY
_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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MENTHOL 5.4 MG
Active ingredient (in each drop)
Menthol 5.4 mg
Purpose
Cough suppressant / Oral anesthetic
Uses temporarily relieves:
cough as may occur with a cold
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. If sore mouth
symptoms do not improve in 7 days, see your dentist or doctor
promptly. These symptoms may be
serious.
Ask a doctor before use if you have:
persistent or chronic cough suchas occurs with smoking, asthma, or
emphysema
cough accompanied by excessive phlegm (mucus)
Stop use and ask 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
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Directions
adults and children 5 years and over - allow 1 drop to dissolve slowly
in mouth. May be repeated every
two hours as necessary or as directed by a doctor.
children under 5 years - ask a doctor
Inactive ingredients: Corn starch, corn syrup, eucalyptus oil, FD&C
blue no. 1, FD&C red no. 40,
glycerin, gum arabic, medium chain triglycerides, natural flavor,
potassium sorbate, soybean oil,
sucrose, and water.
Questions? Or to report an adverse event call 1-800-245-2898, Monday -
Friday, 9AM to 4PM EST
MENTHOL COUGH DROPS
menthol lozenge
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:59 779 -6 53
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDI