Label: PHYSICIANS CARE COUGH AND SORE THROAT- menthol lozenge

  • NDC Code(s): 0924-0150-01, 0924-0150-02
  • Packager: Acme United Corporation
  • 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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  • Drug Facts

    Active ingredient (in each lozenge)

    Menthol 7.6 mg

  • Purpose

    Antitussive (cough suppressant)/oral anesthetic

  • Uses

    Temporarily relieves

    ■ cough as may occur with a cold or inhaled irritants

    ■ occasional minor irritation and sore throat

  • 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 a doctor before use if you have

    ■ persistent or chronic cough occurs with smoking, asthma, or emphysema

    ■ cough accompanied by excessive phlegm (mucus)

    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

  • If pregnant or breast feeding,

    ask a health professional before use.

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

  • Directions

    ■ do not use more than directed

    Adults and children: (12 years and older)

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

    Children under 12 years:

    Do not give to children under 12 years of age.

  • Other information

    ■ 15 calories per lozenge

    ■ store at 59º-86ºF (15º-30ºC)

    ■ protect from moisture & heat

  • Inactive ingredients

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

  • Questions?

    1-800-835-2263

  • Physicians Care Cough and Sore Throat Label

    90306

    Physicians Care®

    Cough and Sore Throat

    Cherry/Eucalyptus Flavor Menthol Lozenges

    Pull To Open

    Individually Wrapped Lozenges

    Menthol 7.6 mg/lozenge

    50 Lozenges

    Cough Sore

  • INGREDIENTS AND APPEARANCE
    PHYSICIANS CARE COUGH AND SORE THROAT 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0150
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SUCROSE (UNII: C151H8M554)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize22mm
    FlavorCHERRYImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0150-0150 in 1 CARTON01/05/2015
    11 in 1 CELLO PACK; Type 0: Not a Combination Product
    2NDC:0924-0150-02125 in 1 CARTON01/05/2015
    21 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/05/2015
    Labeler - Acme United Corporation (001180207)
    Registrant - Unifirst First Aid Corporation (832947092)
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