RICOLA MAX THROAT CARE COOL PEPPERMINT- 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 COOL PEPPERMINT- 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 COOL PEPPERMINT
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.
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
extract of peppermint and a Ricola herb mixture (elder, horehound,
hyssop, lemon balm,
linden flowers, mallow, peppermint, sage, thyme, wild thyme),
glycerin, invert sugar
(fructose/dextrose), natural flavor, starch syrup, sugar
RICOLA MAX THROAT CARE COOL PEPPERMINT
menthol lozenge
Ricola Ag
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:54305-202
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)