Label: MGC HEALTH- cough drops creamy strawberry lozenge
- NDC Code(s): 61658-129-30
- Packager: YUNNAN BAIYAO GROUP CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 31, 2023
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- Active Ingredient(s)
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INGREDIENTS AND APPEARANCE
MGC HEALTH
cough drops creamy strawberry lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61658-129 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 mg PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN 7 mg Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CORN SYRUP (UNII: 9G5L16BK6N) BETA CAROTENE (UNII: 01YAE03M7J) LACTIC ACID (UNII: 33X04XA5AT) POTASSIUM CITRATE (UNII: EE90ONI6FF) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) SODIUM CHLORIDE (UNII: 451W47IQ8X) SUCRALOSE (UNII: 96K6UQ3ZD4) MALIC ACID (UNII: 817L1N4CKP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score score with uneven pieces Shape OVAL Size 21mm Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61658-129-30 30 in 1 BAG; Type 0: Not a Combination Product 09/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/01/2023 Labeler - YUNNAN BAIYAO GROUP CO., LTD (654223122) Registrant - Medical Group Care LLC (085137089)