Label: THROAT AND CHEST CHILI AND LIME- menthol lozenge
- NDC Code(s): 42637-820-01
- Packager: Jakemans (Confectioners) Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
Drug FactsActive Ingredient (in each lozenge)...PurposesClose
Menthol 5mg.........Antitussive (cough suppressant) / oral anesthetic
- INDICATIONS & USAGE
Ask a doctor before use if you have
- persistent or chronic cough as occurs with smoking, asthma or emphysema.
- cough that occurs with excessive phlegm (mucus).
- STOP USE
Stop use and ask a doctor if
- cough persists for man than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
- sore mouth symptoms do not improve in 7 days.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. Close
- DOSAGE & ADMINISTRATION
- adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repear every 2 hours as needed or as directed by a doctor.
- children under 2 years of age: ask a doctor.
- INACTIVE INGREDIENT
Glucose syrup, natural flavors, sugar, water.Close
Questions and Comments?To report serious adverse events, call: 1-866-205-1185Close
- cough due to minor throat and bronchial irritation occurring with the common cold or inhaled irritants.
- occasional minor irritation, pain, sore mouth, and sore throat.
Sore throat warning
If sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.Close
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.Close
- INGREDIENTS AND APPEARANCE
THROAT AND CHEST CHILI AND LIME
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42637-820 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol 5 mg Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) CORN SYRUP (UNII: 9G5L16BK6N) SUCROSE (UNII: C151H8M554) Product Characteristics Color green Score no score Shape OVAL (Lozenge) Size 30mm Flavor LIME (Natural Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42637-820-01 30 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/13/2011 Labeler - Jakemans (Confectioners) Limited (218806669)