MEYER LEMON AND HONEY-COUGH RELIEF LOZENGES (ORAL ANESTHETIC)- menthol lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Quantum, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antitussive (Cough Suppressant) / Oral Anesthetic - cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. - sore mouth symptoms do not improve in 7 days. - cough due to minor throat and bronchial irritation occurring with the common cold and inhaled irritation, - occasional minor irritation, pain, sore mouth, and sore throat.

Authorization status:

OTC monograph final

Summary of Product characteristics

MEYER LEMON AND HONEY-COUGH RELIEF LOZENGES (ORAL ANESTHETIC)-
MENTHOL LOZENGE
QUANTUM, INC.
_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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MEYER LEMON AND HONEY-COUGH RELIEF LOZENGES (ORAL ANESTHETIC)
(In each lozenge)
Organic Menthol 5mg
Antitussive (Cough Suppressant) / Oral Anesthetic
SORE THROAT WARNING: Severe or persistent sore throat or sore throat
accompanied
by high fever, headache, rash, nausea, and vomiting may be serious.
Consult physician
promptly. Do not use more than 2 days or administer to children under
5 years of age
unless directed by a physician.
ASK A DOCTOR BEFORE USE IF YOU HAVE:
- persistent or chronic cough as occurs with smoking, asthma, or
emphysema.
- cough that occurs with excessive phlegm (mucus).
- cough persists for more than 1 week, tends to recur, or is
accompanied by fever,
rash, or persistent headache. A persistent cough may be a sign of a
serious condition.
- sore mouth symptoms do not improve in 7 days.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Adults and children 5 years and over: dissolve lozenge slowly in the
mouth. Repeat every
2 hours as needed or as directed by a doctor. Children under 5years of
age: ask a
doctor.
Store in a cool, dry place.
Organic Brown Rice Syrup, Organic Cane Syrup, Organic Honey, Natural
Meyer Lemon
Flavor and Other Natural Flavors, Organic Slippery Elm Bark Powder,
and Organic
Tumeric.
- cough due to minor throat and bronchial irritation occurring with
the common cold and
inhaled irritation,
- occasional minor irritation, pain, sore mouth, and sore throat.
MEYER LEMON AND HONEY-COUGH RELIEF LOZENGES (ORAL
ANESTHETIC)
menthol lozenge
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:70084-614
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
MENT