Label: THROAT AND CHEST HONEY LEMON AND MENTHOL- menthol lozenge
- NDC Code(s): 42637-813-01, 42637-813-02
- 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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- PRINCIPAL DISPLAY PANEL
Throat and Chest
Honey and Lemon Flavored
With other Natural Flavor
Menthol Cough Suppressant
Made in Boston, England, for over 100 years
using the finest natural ingredients
24 LOZENGES Close
- ACTIVE INGREDIENT
Active Ingredient (in each lozenge)...Purpose
Menthol 5mg.........Antitussive (cough suppressant) / oral anesthetic Close
Uses Temporarily relieves
- cough due to minor throat and brochial 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
- 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 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 mat be a sign of a serious condition.
- sore mouth symptoms do not improve in 7 days.
- PREGNANCY OR BREAST FEEDING
If pregnant of breast-feeding,ask a health professional before use. Close
- 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.
Questions and Comments?
To report serious adverse enets, call: 1-866-205-1185 Close
- INACTIVE INGREDIENT
Inactive Ingredients beta carotene (coloring), glucose syrup, honey, lactic acid, lemon oil (flavoring), natural flavor), sodium lactate, sugar, water. Close
- INGREDIENTS AND APPEARANCE
THROAT AND CHEST HONEY LEMON AND MENTHOL
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42637-813 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (MENTHOL) Menthol 5 mg Inactive Ingredients Ingredient Name Strength Honey Lemon Oil Beta Carotene Lactic Acid Water Sucrose CORN SYRUP Product Characteristics Color yellow (Beta Carotene) Score no score Shape OVAL (Lozenge) Size 30mm Flavor HONEY (Natural flavor) , LEMON (Lemon Oil) Imprint Code ol Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42637-813-01 24 in 1 BOX 2 NDC:42637-813-02 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)