SF MENTHOL COUGH DROP lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fred's Inc.

INN (International Name):

MENTHOL

Composition:

MENTHOL 5.8 mg

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

SF MENTHOL COUGH DROP- MENTHOL LOZENGE
FRED'S INC.
_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._
----------
MENTHOL 5.8 MG
Active ingredient (in each drop)
Menthol 5.8 mg
Purpose
Cough suppressant/
Oral anesthetic
Uses temporarily relieves:
cough as may occur with a cold
occasioinal 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 such as occurs with smoking, asthma, or
emphysema
cough accompanied by excessive phlegm (mucus)
Wehn using htis 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 severe, or irritation, pain, 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.
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 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,
glycrin, gum arabic, potassium
sorbate), eucalyptus oil, FD&C blue #1, FD&C red #40, hydrogenated
starch sydrolysate, isomalt,
N&A flavoring, sucralose & water. Soybean