NDC | 12546-112-30, 12546-112-40, 12546-112-80, 12546-112-89, 12546-112-96 |
Set ID | ff21cf0e-9811-4819-bdfc-17a950e9b114 |
Category | HUMAN OTC DRUG LABEL |
Packager | Mondelez Global LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- Active Ingredient
- Purposes
- Uses
- Warnings
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions
- OTC Principal Display Panel
-
INGREDIENTS AND APPEARANCE
HALLS MENTHO-LYPTUS
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-112 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) POTASSIUM CITRATE (UNII: EE90ONI6FF) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUCROSE (UNII: C151H8M554) Product Characteristics Color blue (LIGHT BLUE WITH BLUE SPECKS) Score no score Shape OVAL Size 21mm Flavor MENTHOL (MENTHO-LYPTUS) Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12546-112-30 30 in 1 BAG; Type 0: Not a Combination Product 04/07/2019 2 NDC:12546-112-14 14 in 1 BAG; Type 0: Not a Combination Product 09/01/2020 3 NDC:12546-112-40 40 in 1 BAG; Type 0: Not a Combination Product 04/07/2019 4 NDC:12546-112-80 80 in 1 BAG; Type 0: Not a Combination Product 04/07/2019 5 NDC:12546-112-89 200 in 1 BAG; Type 0: Not a Combination Product 04/07/2019 6 NDC:12546-112-96 96 in 1 BAG; Type 0: Not a Combination Product 04/07/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/07/2019 Labeler - Mondelez Global LLC (050964956)