Country: United States
Language: English
Source: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
HEB
MENTHOL
MENTHOL 5.8 mg
ORAL
OTC DRUG
Purpose Cough suppressant / Oral anesthetic Uses temporarily relieves: - cough as may occur with a cold - occasional minor irritation and sore throat Stop use and ask doctor if - cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. - sore throat is severe, or irritation, pain or redness lasts or worsens - sore mouth does not improve in 7 days
OTC monograph final
SF MENTHOL COUGH DROP- MENTHOL LOZENGE HEB _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._ ---------- MENTHOL 5.8 MG ACTIVE INGREDIENT (IN EACH DROP) Menthol 5.8 mg PURPOSE Cough suppressant / Oral anesthetic USES temporarily relieves: cough as may occur with a cold 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, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or 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 DOCTOR IF cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. sore throat is severe, or irritation, pain or redness lasts or worsens sore mouth does not improve in 7 days IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. DIRECTIONS adults and children 5 years and over - dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor. children under 5 years - ask a doctor OTHER INFORMATION 6 calories per drop Excess consumption may cause a laxative effect. INACTIVE INGREDIENTS: Acesulfame potassium (non-nutritive sweetener), corn starch, eucalyptus oil, FD&C blue no. 1, FD&C red no. 40, glycerin, gum arabic, isomalt, maltitol syrup, medium chain triglycerides, natural & artificial flavors, potassium sorbate, soybean oil, sucralose (non-nutritive sweetener) and water. QUESTIONS? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST SF MENTHOL COUGH DROP menth Read the complete document