Label: HALLSSUGAR FREE EXTRA SUGAR FREE EXTRA STRONG MENTHOL- menthol lozenge
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Contains inactivated NDC Code(s)
NDC Code(s): 12546-314-09 - Packager: Mondelez Global LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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Drug Label Information
Updated February 7, 2014
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- Active Ingredients
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INGREDIENTS AND APPEARANCE
HALLSSUGAR FREE EXTRA SUGAR FREE EXTRA STRONG MENTHOL
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-314 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 18 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 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 (white with blue speckles) Score no score Shape SQUARE Size 21mm Flavor MENTHOL (Sugar Free Extra Strong) Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12546-314-09 09 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 02/04/2014 Labeler - Mondelez Global LLC (050964956) Establishment Name Address ID/FEI Business Operations Mondelez Canada Inc. 246791201 manufacture(12546-314)