Label: MGC HEALTH- cough drops assorted citrus vitamin c lozenge

  • NDC Code(s): 61658-126-30, 61658-126-80
  • 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 July 3, 2023

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  • Active Ingredient(s)

    Menthol 2.7

  • 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

    ■ 10 calories per drop ■ contains: SOY.

  • Inactive ingredients


    MENTHOL
    BETA CAROTENE
    CITRIC ACID
    ASCORBIC ACID
    ACESULFAME POTASSIUM
    GLUCOSE SYRUP
    FD&C RED NO. 40
    SOY LECITHIN
    SUCROSE
    SODIUM ASCORBATE
    WATER

  • QUESTIONS

    Call 2396311907 or visit our website: www.mgc.us

  • Package Label - Principal Display Panel

    Citrus Drops 80

    Assorted Citrus Drops 80 NDC 61658-126-80

  • INGREDIENTS AND APPEARANCE
    MGC HEALTH 
    cough drops assorted citrus vitamin c lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61658-126
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.7 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    Product Characteristics
    ColororangeScorescore with uneven pieces
    ShapeOVALSize21mm
    FlavorMENTHOLImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61658-126-8080 in 1 BAG; Type 0: Not a Combination Product02/12/2023
    2NDC:61658-126-3030 in 1 BAG; Type 0: Not a Combination Product07/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/12/2023
    Labeler - YUNNAN BAIYAO GROUP CO., LTD (654223122)
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