RICOLA MAX THROAT CARE HONEY LEMON- menthol lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ricola Ag

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

temporarily relieves: - cough due to a cold or inhaled irritants - occasional minor irritation and pain due to sore throat or sore mouth - persistent or chronic cough such as occurs with smoking, asthma, or emphysema - cough accompanied by excessive phlegm (mucus) - cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  These could be signs of a serious condition. - sore mouth does not improve in 7 days - irritation, pain, or redness persists or worsens

Authorization status:

OTC monograph final

Summary of Product characteristics

RICOLA MAX THROAT CARE HONEY LEMON- MENTHOL LOZENGE
RICOLA AG
_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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RICOLA MAX THROAT CARE HONEY LEMON
DRUG FACTS
PURPOSE
Cough suppressant, Oral anesthetic
ACTIVE INGREDIENT (IN EACH DROP)
Menthol, 8.3 mg
USES
temporarily relieves:
cough due to a cold or inhaled irritants
occasional minor irritation and pain due to sore throat or sore mouth
WARNINGS
​SORE THROAT WARNINGS:
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 may be serious.
do not use in children under 6 years of age unless directed by a
doctor.
ASK 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 A DOCTOR IF
cough persists for more than 1 week, tends to recur, or is accompanied
by fever,
rash, or persistent headache. These could be signs of a serious
condition.
sore mouth does not improve in 7 days
irritation, pain, or redness persists or worsens
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
adults and children 6 years and older: dissolve 1 drop slowly in the
mouth. Repeat
every 2 hours as needed or as directed by a doctor.
children under 6 years: ask a doctor
do not bite or chew
OTHER INFORMATION
Store in a dry place
INACTIVE INGREDIENTS
citric acid, extract of a Ricola herb mixture (elder, horehound,
hyssop, lemon balm,
linden flowers, mallow, peppermint, sage, thyme, wild thyme),
glycerin, honey, lemon
juice concentrate, natural color (beta-carotene), natural flavors,
starch syrup, sugar
RICOLA MAX THROAT CARE HONEY LEMON
Ricola Ag
menthol lozenge
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:54305-203
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIE