Label: THROAT AND CHEST ANISE AND MENTHOL- menthol lozenge
- NDC Code(s): 42637-810-01, 42637-810-02
- 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
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
- ASK DOCTOR
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).
- INDICATIONS & USAGE
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
- INACTIVE INGREDIENT
Inactive Ingredients anise oil (flavoring), caramel color, eucalyptus oil (flavoring), glucose syrup, natural flavor, sugar, water. Close
Questions and Comments?
To report serious adverse enets, call: 1-866-205-1185 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.
- INGREDIENTS AND APPEARANCE
THROAT AND CHEST ANISE AND MENTHOL
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42637-810 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 Anise Oil (UNII: 6Y89129C8H) Eucalyptus Oil (UNII: 2R04ONI662) Caramel (UNII: T9D99G2B1R) Malic Acid (UNII: 817L1N4CKP) Sucrose (UNII: C151H8M554) Water (UNII: 059QF0KO0R) Product Characteristics Color black (Caramel (black)) Score no score Shape OVAL (Lozenge) Size 30mm Flavor ANISE (Anise Flavoring) Imprint Code ol Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42637-810-01 24 in 1 BOX 2 NDC:42637-810-02 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)