PHYSICIANS CARE COUGH AND SORE THROAT- menthol lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

Acme United Corporation

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antitussive (cough suppressant)/oral anesthetic Temporarily relieves ■ cough as may occur with a cold or inhaled irritants ■ occasional minor irritation and sore throat

Authorization status:

OTC monograph final

Summary of Product characteristics

                                PHYSICIANS CARE COUGH AND SORE THROAT- MENTHOL LOZENGE
ACME UNITED CORPORATION
_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._
----------
PHYSICIANS CARE COUGH AND SORE THROAT
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH LOZENGE)_
Menthol 7.6 mg
_PURPOSE_
Antitussive (cough suppressant)/oral anesthetic
_USES_
TEMPORARILY RELIEVES
■ cough as may occur with a cold or inhaled irritants
■ occasional minor irritation and sore throat
_WARNINGS_
SORE THROAT WARNING: If sore throat is severe, persists for more than
2 days, is
accompanied or followed by fever, headache, rash, nausea, or vomiting,
consult a
doctor promptly. These symptoms may be serious.
ASK A DOCTOR BEFORE USE IF YOU HAVE
■ persistent or chronic cough 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
IF PREGNANT OR BREAST FEEDING,
ask a health professional before use.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
_DIRECTIONS_
■ DO NOT USE MORE THAN DIRECTED
ADULTS AND CHILDREN: (12 YEARS AND OLDER)
Allow 1 lozenge to dissolve slowly in the mouth. May be repeated every
2 hours as
necessary or as directed by a doctor.
CHILDREN UNDER 12 YEARS:
Do not give to children under 12 years of age.
_OTHER INFORMATION_
■ 15 calories per lozenge
■ store at 59º-86ºF (15º-30ºC)
■ protect from moisture & heat
_INACTIVE INGREDIENTS_
cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose
_QUESTIONS?_
1-800-835-2263
PHYSICIANS CARE COUGH AND SORE THROAT LABEL
90306
Physicians Care®
Cough and Sore Throat
Cherry/Eucalyptus Flavor Menthol Lozenges
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