Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:


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INN (International Name):



MENTHOL 5.8 mg

Prescription type:


Authorization status:

OTC monograph final

Summary of Product characteristics

                                MENTHOL COUGH DROP- SF MENTHOL LOZENGE
_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._
Active Ingredient
Menthol 5.8mg
Cough suppressant/Oral anesthetic
Temporarily relieves:
cough as may occur with a cold
occasional minor irritation 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, 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 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 consult 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 sever, 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 this and all drugs out of the reach of
children. In case of accidental overdose, get medical
help or contact a Poison Control Center right away.
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
Other information
6 calories per drop
Excess consumption may cause a laxative effect
Inactive Ingredients: acesulfame potassium, blue
flakes (FD&C blue #1, glycerin, gum arabic, potassium
sorbate), eucalyptus oil, FD&C blue #1, FD&C Red #40,
hydrogenated starch hydrolysate, isomalt, N&A flavoring,
sucralose, & water. Soybean oil and corn starch used
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