Label: LEADER COUGH DROPS MENTHOL FLAVOR- menthol lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 49781-012-30 - Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated November 25, 2013
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- LEADER Cough Drops Menthol Flavor
- Active ingredient (in each drop)
- Uses
- Warnings Sore throat warning:
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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)
- Directions
- Other information:
- Inactive ingredients:
- Questions?
- DISTRIBUTED BY
- LEADER Cough Drops Menthol Flavor 30 Count (49781-012-30)
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INGREDIENTS AND APPEARANCE
LEADER COUGH DROPS MENTHOL FLAVOR
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-012 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.4 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) ACACIA (UNII: 5C5403N26O) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C RED NO. 40 (UNII: WZB9127XOA) CORN SYRUP (UNII: 9G5L16BK6N) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) SOYBEAN OIL (UNII: 241ATL177A) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color blue Score no score Shape OVAL (Oval) Size 12mm Flavor Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49781-012-30 30 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/25/2013 Labeler - Cardinal Health (097537435) Establishment Name Address ID/FEI Business Operations Bestco, Inc. 002149136 manufacture(49781-012)