NDC | 42637-824-01, 42637-824-02 |
Set ID | 6d5fe101-2e06-2208-e053-2a91aa0a2202 |
Category | HUMAN OTC DRUG LABEL |
Packager | Jakemans (Confectioners) Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
-
PURPOSE
JAKEMANS® Boston ENGLAND Est 1907
Throat & Chest™ Peppermint Flavored Menthol Cough Suppressant Oral Anesthetic
Made in Boston, England, for over 100 years using the finest natural ingredients.
30 Lozenges
Jakemans famous and original Throat & Chest Lozenges are made with the finest natural ingredients, carefully blended with soothing menthol to obtain a unique mouth watering and refreshing taste. Once tasted they will be your favorite soothing lozenge!
Manufactured by:
Jakemans (Confectioners) Ltd.
Boston PE20 2JA, United Kingdom
US Toll Free: 1-866-205-1185
www.jakemans.us
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
Warnings
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.
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 more 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.If pregnant or breast-feeding, ask a health professional before use.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JAKEMANS THROAT AND CHEST PEPPERMINT
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42637-824 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 mg Inactive Ingredients Ingredient Name Strength CORN SYRUP (UNII: 9G5L16BK6N) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) PEPPERMINT OIL (UNII: AV092KU4JH) Product Characteristics Color green Score no score Shape OVAL Size 30mm Flavor PEPPERMINT Imprint Code ol Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42637-824-01 30 in 1 PACKAGE; Type 0: Not a Combination Product 12/11/2013 2 NDC:42637-824-02 24 in 1 PACKAGE; Type 0: Not a Combination Product 12/11/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/11/2013 Labeler - Jakemans (Confectioners) Ltd. (218806669) Establishment Name Address ID/FEI Business Operations Jakemans (Confectioners) Ltd. 218806669 manufacture(42637-824) , relabel(42637-824) , repack(42637-824)