Country: United States
Language: English
Source: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Topco Associates LLC
ORAL
OTC DRUG
Uses temporarily relieves: - cough as may occur with a cold - ocassional minor irritation and sore throat Uses temporarily relieves: - cough as may occur with a cold - ocassional minor irritation and sore throat Stop use and consult a doctor if - sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
OTC monograph final
HONEY LEMON MENTHOL COUGH DROPS- HONEY LEMON MENTHOL PASTILLE TOPCO ASSOCIATES LLC _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._ ---------- HONEY LEMON MENTHOL COUGH DROPS Active ingredient 7.5 mg Cough Suppressant Oral anesthetic Uses temporarily relieves: cough as may occur with a cold ocassional minor irritation and sore throat Uses temporarily relieves: cough as may occur with a cold ocassional minor irritation and sore throat Warnings Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age. Ask a doctor before use if you have a severe throat accompanied by difficulty in breathing or that last more than 2 days a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting Stop use and consult a doctor if sore mouth symptons do not improve in 7 days or if irritation, pains 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. In case of accidental overdose, get medical help or contact a Poison Control Center right In case of accidental overdose, get medical help or contact a Poison Control Center right away. Directions Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor. Children under 12 years and under do not use Store in a cool and dry place 10 calories per drop citric acid, honey, flavors, glucose syrup, sucrose, turmeric Questions? or to report and adverse event call: 1-800-423-0139 HONEY LEMON MENTHOL COUGH DROPS honey lemon menthol pastille PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:76162-024 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MO Read the complete document