- Active Ingredient
- Purpose
- Uses
- Warnings
- Stop Use and Ask a Doctor if
- Keep out of reach of children.
- Directions
- Other Information
- Inactive ingredients
- Questons
- OTC Principal Display Panel
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INGREDIENTS AND APPEARANCE
HALLS SUGAR FREE EXTRA STRONG MENTHOL
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-313 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ISOMALT (UNII: S870P55O2W) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) WATER (UNII: 059QF0KO0R) Product Characteristics Color white (with blue specks) Score no score Shape OVAL Size 21mm Flavor MENTHOL (Sugar Free Extra Strong Menthol) Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12546-313-25 25 in 1 BAG; Type 0: Not a Combination Product 09/12/2016 2 NDC:12546-313-02 02 in 1 PACKAGE; Type 0: Not a Combination Product 09/12/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/12/2016 Labeler - Mondelez Global LLC (050964956) Establishment Name Address ID/FEI Business Operations Mondelez Canada Inc. 246791201 manufacture(12546-313)