Label: HALLS SUGAR FREE BLACK CHERRY- menthol lozenge
- NDC Code(s): 12546-104-25, 12546-104-30, 12546-104-70
- Packager: Mondelez Global LLC
- 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 October 4, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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 SUGAR FREE BLACK CHERRY
menthol lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12546-104 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.8 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) ISOMALT (UNII: S870P55O2W) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) WATER (UNII: 059QF0KO0R) Product Characteristics Color red (dark red) Score no score Shape OVAL Size 21mm Flavor CHERRY (Black Cherry) Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12546-104-25 25 in 1 BAG; Type 0: Not a Combination Product 06/10/2019 2 NDC:12546-104-30 30 in 1 BAG; Type 0: Not a Combination Product 06/10/2019 06/21/2022 3 NDC:12546-104-70 70 in 1 BAG; Type 0: Not a Combination Product 06/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/10/2019 Labeler - Mondelez Global LLC (050964956) Establishment Name Address ID/FEI Business Operations Mondelez Canada Inc 246791201 manufacture(12546-104)