Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)
Mondelez Global LLC
ORAL
OTC DRUG
OTC monograph final
HALLS HONEY LEMON- MENTHOL LOZENGE MONDELEZ GLOBAL 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._ ---------- DRUG FACTS ACTIVE INGREDIENT (per drop) Menthol 8.8 mg PURPOS ESUS ES temporarily relieves cough due to a cold occasional minor irritation or sore throat WARNINGS Les hele dokumentetASK 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 KEEP OUT OF REACH OF CHILDREN DIRECTIONS adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed. children under 5 years: ask a doctor OTHER INFORMATION 15 calories per drop CONTAINS: SOY. CONTAINS: SOY. INACTIVE INGREDIENTS QUES TIONS Call 1-800-524-2854, Monday to Friday, 9 AM-6PM Eastern Time or visit our website at www.gethalls.com OTC PRINCIPAL DISPLAY PANEL HALLS HONEY LEMON menthol lozenge PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:12546 -320 ROUTE OF ADMINISTRATION ORAL Mondelez Global LLC ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH MENTHO L (UNII: L7T10 EIP3A) (Mentho l - UNII:L7T10 EIP3A) Me ntho l 8 .8 mg INACTIVE INGREDIENTS INGREDIENT NAME ST