SANATOS LOZENGES- menthol lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pharmadel LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

For the temporary relief of - minor irritation and sore throats - cough as may occur with a cold

Authorization status:

OTC monograph final

Summary of Product characteristics

SANATOS LOZENGES- MENTHOL LOZENGE
PHARMADEL 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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SANATOS SORE THROAT LOZENGES HONEY-LEMON
DRUG FACTS
_ACTIVE INGREDIENT & PURPOSES_
_ACTIVE INGREDIENTS (IN EACH LOZENGE)_
_PURPOSES_
Menthol 5.5 mg................................................
Cough suppressant / oral anesthetic
US ES
For the temporary relief of
minor irritation and sore throats
cough as may occur with a cold
WARNINGS
SORE THROAT WARNING: if sore throat is severe persists for more than 2
days, is accompanied or
followed by high fever, headache, rash, nausea or vomiting, consult a
doctor promptly. These may be
serious.
ASK A DOCTOR BEFORE USE IF YOU HAVE
persistent or chronic cough such as occurs with smoking, asthma or
emphysema
a cough that is accompanied by excessive phlegm (mucus)
STOP USE AND ASK A DOCTOR IF
a 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.
KEEP OUT OF THE REACH OF CHILDREN.
DIRECTIONS
ADULT AND CHILDREN 3 TO UNDER 12 YEARS OF AGE: allow the lozenge to
dissolve one (1) drop slowly
in mouth
repeat every 2 hours as needed or as directed by doctor
CHILDREN UNDER 3 YEARS OF AGE: consult a doctor
OTHER INFORMATION
store in cool dry place below 77º F
protect from heat and light
do not use if package is torn or broken
INACTIVE INGREDIENTS
INACTIVE INGREDIENTS
ascorbic acid, citric acid monohydrate, cordia dichotoma fruit, corn
syrup, eucalyptus oil, hyssopus
ofcinalis owering top, greater galangal, justicia adhatoda leaf,
licorice, long pepper, natural honey
avor, natural lemon avor, sucrose.
QUESTIONS & COMMENTS?
1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
PRINCIPAL DISPLAY PANEL
SanaTos®
Sore Throat Lozenges/Pastillas para el dolor de garganta
Relieves Cough/Alivia la Tos
Soothes So