Drug Facts
Active ingredient (in each drop)
Menthol 7.6 mg
Physicians Care Cough And Sore Throat Lozenge
FDA Label NDC 0924-0150
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product Physicians Care Cough And Sore Throat (NDC 0924-0150). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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
Directions
■ do not use more than directed
Adults and children: (12 years and older)
Allow 1 drop to dissolve slowly in the mouth. May be repeated every hour 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 drop
■ store at 59°-86°F (15°-30°C)
■ protect from moisture & heat
Inactive Ingredients
cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose
Questions Or Comments?
1-800-835-2263
Physicians Care Cough And Sore Throat Label
Physicians Care®
Cough and Sore Throat
Cherry Flavored Menthol Lozenges
Pull To Open
Individually Wrapped Lozenges
50 Lozenges (7.6 MG of Menthol Each)
* Please review the disclaimer below.
