Label: MGC HEALTH- cough drops creamy strawberry lozenge

  • NDC Code(s): 83173-129-30
  • Packager: Medical Group Care LLC
  • 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)

    Menthol 2.5 mg

    Pactin 7 mg

  • Purpose

    Pectin: oral demulcent

    Menthol: cough suppressant, oral anesthetic

  • Use

    temporarily relieves the following symptoms associated with sore mouth and sore throat:

    minor discomfort

    irritated areas

  • 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 ■ sore mouth does not improve in 7 days m, irritation, pain, or redness persists or worsens.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 5 ears and over: dissolve 1 or 2 drops (one at a time) slowly in the mouth. Repeat as needed

    children under 5 years: ask a doctor.

  • Other information

    ■ 15 calories per drop ■ contains: SOY.

  • Inactive ingredients

    beta carotene, citric acid, FD&C blue 2, FD&C red 40, flavors, glucose syrup, lactic acid, malle acid, potassium citrate, soy lecithin, sucrose, titanium dioxide,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 30CT30 Drops NDC: 83173-129-30

  • INGREDIENTS AND APPEARANCE
    MGC HEALTH 
    cough drops creamy strawberry lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83173-129
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN7 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeOVALSize21mm
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83173-129-3030 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 not finalpart35609/01/2023
    Labeler - Medical Group Care LLC (085137089)
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