Country: United States
Language: English
Source: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Acme United Corporation
ORAL
OTC DRUG
Antitussive (cough suppressant)/oral anesthetic Temporarily relieves ■ cough as may occur with a cold or inhaled irritants ■ occasional minor irritation and sore throat
OTC monograph final
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 Pull To Open Indivi Read the complete document