Label: MGC HEALTH- cough drops black cherry sugar free lozenge
- NDC Code(s): 61658-127-25, 61658-127-70
- Packager: YUNNAN BAIYAO GROUP CO., LTD
- 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 August 31, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- QUESTIONS
- Package Label - Principal Display Panel
-
INGREDIENTS AND APPEARANCE
MGC HEALTH
cough drops black cherry sugar free lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61658-127 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) EUCALYPTUS OIL (UNII: 2R04ONI662) FD&C RED NO. 40 (UNII: WZB9127XOA) ISOMALT (UNII: S870P55O2W) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) WATER (UNII: 059QF0KO0R) ASPARTAME (UNII: Z0H242BBR1) Product Characteristics Color red 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:61658-127-25 25 in 1 BAG; Type 0: Not a Combination Product 09/01/2023 2 NDC:61658-127-70 70 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 final part341 09/01/2023 Labeler - YUNNAN BAIYAO GROUP CO., LTD (654223122) Registrant - Medical Group Care LLC (085137089)