Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
ADVANCED FIRST AID, INC.
ORAL
OTC DRUG
Cough suppressant / Oral Anesthetic Uses: temporarily relieves • cough as may occur with a cold • occasional minor irritation and sore throat
OTC monograph final
ADVANCED HONEY LEMON COUGH DROPS- COUGH DROPS LOZENGE ADVANCED FIRST AID, INC. _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 (IN EACH LOZENGE) - Menthol 8.6mg 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. These smptoms may be serious. ASK A DOCTOR BEFORE USE IF YOU HAVE: • persistent or chronic cough such as ocurs with smoking, asthma, or emphysema • cough accompanied by excessive phlegm (mucus) STOP USE AND CONSULT A 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 BABY, ask a health professional before use. KEEP THIS AND ALL DRUGS OUT OF 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 OLDER: Allow lozenge to dissolve slowly in mouth; may be repeated every hour as necessary or as directed by a doctor. • CHILDREN UNDER 5 YEARS: Consult a doctor. corn syrup, eucalyptus oil, D&C Yellow #10, FD& C Yellow #6, honey, lemon oil, sucrose ADVANCED HONEY LEMON COUGH DROPS cough drops lozenge PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 70 6 0 -121 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A) MENTHOL 8 .6 INACTI Lees het volledige document