Label: UNISHIELD CHERRY COUGH- menthol lozenge

  • 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 March 15, 2022

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  • 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 finalpart34103/01/2021
    Labeler - Unishield (790677053)
    Registrant - Unifirst First Aid Corporation (832947092)
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