Label: MGC HEALTH- cough drops black cherry sugar free lozenge

  • NDC Code(s): 83173-127-25, 83173-127-70
  • 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 August 31, 2023

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  • Active Ingredient(s)

    Menthol 5.8

  • Purpose

    Purposes cough suppressant, oral anesthetic

  • Use

    temporary relieves: ■ cough due to cold ■ occasional minor irritation or sore throat

  • Warnings

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.

  • ASK DOCTOR

    Ask a doctor before use if you have: ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough accompanied by excessive phlegm (mucus).

  • STOP USE

    Stop use and ask a doctor if ■ cough persists for more than 1 week, tends to recur, or is accompained by fever, rash, or persistent headache. These could be signs of a serius condition. ■ sore mouth does not improve in 7 days ■ irritation, pain, or redness persists or worsens.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    • adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.

    • children under 5 years: ask a doctor.

  • Other information

    phenylketonurics: contains phenylalanine 2 mg per drop

    excessive consumption may have a laxative effect
    contains: SOY.

    -5 calories per drop

  • Inactive ingredients

    Acesulfame potassium, aspartame, eucalyptus oil, maltitol, FD&C blue 1. FD&C red 40, flavors. isomalt, soy lecithin, sucralose, water.

  • QUESTIONS

    Call Toll-Free 866-306-9136 or visit our website: www.mgc.us

    customerservice@mgc.us

  • Package Label - Principal Display Panel

    MGC label 25CT25 Drops NDC: 83173-127-25

  • INGREDIENTS AND APPEARANCE
    MGC HEALTH 
    cough drops black cherry sugar free lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83173-127
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorredScorescore with uneven pieces
    ShapeOVALSize21mm
    FlavorMENTHOLImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83173-127-2525 in 1 BAG; Type 0: Not a Combination Product09/01/2023
    2NDC:83173-127-7070 in 1 BAG; Type 0: Not a Combination Product09/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2023
    Labeler - Medical Group Care LLC (085137089)
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