Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)
Dabur International Limited
ORAL
OTC DRUG
Purpose Cough suppressant / Oral anesthetic Uses temporarily relieves - cough as may occur with a cold or inhaled irritants - occasional minor irritation, pain, sore mouth and sore throat
OTC monograph final
DABUR HONITUS HERBAL COUGH DROPS ORANGE- MENTHOL LOZENGE DABUR INTERNATIONAL LIMITED _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._ ---------- DABUR HONITUS HERBAL COUGH DROPS - ORANGE _DRUG FACTS_ _ACTIVE INGREDIENT (IN EACH LOZENGE)_ Menthol 5.7 mg _PURPOSE_ Cough suppressant / Oral anesthetic _USES_ temporarily relieves cough as may occur with a cold or inhaled irritants occasional minor irritation, pain, sore mouth and sore throat _WARNINGS_ SORE THROAT WARNING: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. 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 A DOCTOR IF cough lasts more than 7 days, tends to recur, or occurs with fever, rash or persistent headache. These could be signs of a serious condtion. sore mouth does not improve in 7 days irritation, pain or redness persist or worsen KEEP OUT OF REACH OF CHILDREN. _DIRECTIONS_ adults and children 5 years and over: dissolve 1 lozenge slowly in the mouth repeat every 2 hours as needed children under 5 years: ask a doctor _OTHER INFORMATION_ store at room temperature in a dry place _INACTIVE INGREDIENTS_ Artificial orange flavor, Corn syrup, FD& yellow #6 (Sunset yellow FCF), Ginger ( _Zingiber_ _officinalis_) [Rhizome], Honey, Indian Gooseberry ( _Phyllanthus emblica_) [Fruit], Licorice ( _Glycyrrhiza glabra_) [Root], Sucrose, Turmeric ( _Curcuma longa_) [Rhizome], Water Mfd. for Dabur International Ltd, Jebel Ali Free zone, Street No. N406, P.O. Box: 16944, Dubai, U.A.E. COUNTRY OF ORIGIN: India FOR ADVERSE EVENT REPORTING: Dabur International Ltd. 5 Independence Way - Suite 300 / Office # 46 & 50 Princeton, NJ 08540, Telephone: 609-514-5100 _DABUR HONITUS Đọc toàn bộ tài liệu