Label: MEDI-FIRST HONEY LEMON COUGH DROPS- menthol 8.6 mg lozenge
MEDI-FIRST PLUS HONEY LEMON COUGH DROPS- menthol 8.6 mg lozenge
- NDC Code(s): 47682-840-25, 47682-841-25
- Packager: Unifirst First Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 March 15, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each drop)
- Purpose
- Uses
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Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.
- If pregnant or breast-feeding,
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Medi-First Cough Drop Label
- Medi-First Plus Honey Lemon Label
-
INGREDIENTS AND APPEARANCE
MEDI-FIRST HONEY LEMON COUGH DROPS
menthol 8.6 mg lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-840 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 8.6 mg Inactive Ingredients Ingredient Name Strength CORN SYRUP (UNII: 9G5L16BK6N) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) EUCALYPTUS OIL (UNII: 2R04ONI662) HONEY (UNII: Y9H1V576FH) LEMON OIL (UNII: I9GRO824LL) SUCROSE (UNII: C151H8M554) Product Characteristics Color yellow Score no score Shape OVAL Size 22mm Flavor HONEY (Lemon) Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-840-25 125 in 1 BOX; Type 0: Not a Combination Product 03/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/18/2019 MEDI-FIRST PLUS HONEY LEMON COUGH DROPS
menthol 8.6 mg lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47682-841 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 8.6 mg Inactive Ingredients Ingredient Name Strength CORN SYRUP (UNII: 9G5L16BK6N) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) EUCALYPTUS OIL (UNII: 2R04ONI662) HONEY (UNII: Y9H1V576FH) LEMON OIL (UNII: I9GRO824LL) SUCROSE (UNII: C151H8M554) Product Characteristics Color yellow Score no score Shape OVAL Size 22mm Flavor HONEY (Lemon) Imprint Code P Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47682-841-25 125 in 1 BOX; Type 0: Not a Combination Product 03/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/18/2019 Labeler - Unifirst First Aid Corporation (832947092)