Country: United States
Language: English
Source: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Sound Body
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 consult doctor if - cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could besigns 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
MENTHOL COUGH DROP- CHERRY MENTHOL LOZENGE SOUND BODY _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._ ---------- ACTIVE INGREDIENT MENTHOL 5.8MG Active ingredient (in each drop) Menthol 5.8mg Purpose Cough suppressant/Oral anesthetic Uses temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat 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) When using this product do not exceed recommended dosage Stop use and consult doctor if cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could besigns 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 this and all drugs out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Directions adults and children 5 years and over allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor. children under 5 years ask a doctor Other information 10 calories per drop Inactive ingredients: Eucalyptus oil, FD&C red no. 40, glucose syrup, N&A flavoring, sucrose and water. Soybean oil and corn starch used as processing aids. Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST MENTHOL COUGH DROP cherry Read the complete document