SF 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:

DZA Brands LLC

INN (International Name):

MENTHOL

Composition:

MENTHOL 5.8 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Cough suppressant/ Oral anesthetic Uses temporarily relieves: cough as may occur with a cold or inhaled irritants occasional minor irritation and sore throat 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 or redness lasts or worsens sore mouth does not improve in 7 days

Authorization status:

OTC monograph final

Summary of Product characteristics

SF MENTHOL COUGH DROPS- MENTHOL LOZENGE
DZA BRANDS LLC
_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 5.8 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 or inhaled irritants
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. These symptoms
may be serious.
Ask a doctor before use if you have:
persistent or chronic cough such as occurs with smoking, ashtma, 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 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 this and all drugs out of the 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 doctor.
children under 5 years ask a doctor
Other information
6 calories per drop
Excess consumption may cause laxative effect.
Inactive ingredients: acesulfame potassium, eucalyptus oil, FD&C Blue
#1, FD&C Red #40, flavoring,
gum arabic, hydrogenated starch hydrolysate, isomalt, sucralose, and
water. Soybean oil used as
processing aid.
SF MENTHOL COUGH DROPS
menthol lozenge
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:55316 -0 24
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
IN