Label: MGC HEALTH- cough drops menthol sugar-free lozenge
- NDC Code(s): 83173-113-25, 83173-113-70
- Packager: Medical Group Care 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 May 25, 2023
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- Active Ingredient(s)
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INGREDIENTS AND APPEARANCE
MGC HEALTH
cough drops menthol sugar-free lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83173-113 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 SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) FD&C RED NO. 40 (UNII: WZB9127XOA) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ISOMALT (UNII: S870P55O2W) EUCALYPTUS OIL (UNII: 2R04ONI662) ASPARTAME (UNII: Z0H242BBR1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM CITRATE (UNII: EE90ONI6FF) MALTITOL (UNII: D65DG142WK) Product Characteristics Color blue Score score with uneven pieces Shape OVAL Size 21mm Flavor MENTHOL Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83173-113-25 25 in 1 BAG; Type 0: Not a Combination Product 02/12/2023 2 NDC:83173-113-70 70 in 1 BAG; Type 0: Not a Combination Product 02/12/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/12/2023 Labeler - Medical Group Care LLC (085137089)