- Active Ingredient
- Purposes
- Uses
- Warnings
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions
- OTC Principal Display Panel
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INGREDIENTS AND APPEARANCE
HALLS EXTRA STRONG MENTHOL
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-311 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 15 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POTASSIUM CITRATE (UNII: EE90ONI6FF) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) Product Characteristics Color white (white with blue specks) Score no score Shape OVAL Size 21mm Flavor MENTHOL (Extra Strong Menthol) Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12546-311-30 30 in 1 BAG; Type 0: Not a Combination Product 08/08/2016 2 NDC:12546-311-02 02 in 1 BAG; Type 0: Not a Combination Product 08/08/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 08/08/2016 Labeler - Mondelēz Group LLC (050964956) Establishment Name Address ID/FEI Business Operations Mondelēz Canada Inc. 246791201 manufacture(12546-311)