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:

Dollar General Corporation

INN (International Name):

MENTHOL

Composition:

MENTHOL 5.4 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 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 seious 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
DOLLAR GENERAL CORPORATION
----------
MENTHOL 5.4MG
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 for 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 of 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)
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 seious
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 - dissolve 1 lozenge slowly in
mouth. Repeat every
2 hours as needed or ad directed by a doctor.
children under 5 years - ask a doctor
OTHER INFORMATION
10 calories per drop
do not use if bag is torn or open
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
flavors, potassium
sorbate, soybean oil, sucrose and water.
Questions? 1-888-309-9030
MENTHOL COUGH DROPS
menthol lozenge
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55910-051
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
5.4 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PRODUCT CHARACTERISTICS
COLOR
blue (li