Label: UNISHIELD CHERRY COUGH- menthol lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each drop)

    Menthol 7.6 mg

  • PURPOSE

    Purpose

    Antitussive (cough suppressant)/oral anesthetic

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves

    • cough as may occur with a cold or inhaled irritants
    • occasional minor irritation and sore throat
  • WARNINGS

    Warnings

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

  • ASK DOCTOR

    Ask a doctor before use

    • 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 accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
    • sore mouth does not improve in 7 days
    • irritation, pain, or redness persists or worsens
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed

    Adults and children: (12 years and older)

    Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.

    Children under 12 years:

    Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • 15 calories per drop
    • store at 59º-86ºF (15º-30ºC)
    • protect from moisture & heat
  • INACTIVE INGREDIENT

    Inactive ingredients:

    cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose

  • PURPOSE

    Questions or comments? 800-480-5855

  • PRINCIPAL DISPLAY PANEL

    Unishield

    Cough Drop

    Cough Suppressant/Oral Anesthetic

    50 Drops/Individually Wrapped

    Cherry Flavored

    Menthol 7.6 mg

    Pull To Open

    • Temporarily relieves sore throat and cough

    • Pleasant tasting formula

    • Menthol vapors ease congestion

    Compare active ingredients to:

    Hall®

    Registered Trademark of Warner-Lambert

    Individually Wrapped Cough Drops

    050R

  • INGREDIENTS AND APPEARANCE
    UNISHIELD CHERRY COUGH 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-0505
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM7.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize22mm
    FlavorCHERRYImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-0505-550 in 1 BOX; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/01/2021
    Labeler - Unishield (790677053)
    Registrant - Unifirst First Aid Corporation (832947092)