Label: THERASTAT, CHERRY- cherry cough drops lozenge

  • NDC Code(s): 50332-0147-4, 50332-0147-7, 50332-0147-8
  • Packager: HART Health
  • 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 August 9, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient (in each lozenge)

    Menthol 7 mg

  • PURPOSE

    Purpose

    Cough suppressant/oral anesthetic

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves sore throat and cough occurring with a cold

  • 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 right away

  • ASK DOCTOR

    Ask a doctor before use if you have

    • a cough acccompanied by excessive phlegm (mucus)
    • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • STOP USE

    Stop use and ask a doctor if:

    • sore mouth does improve in 7 days
    • irritation, pain or redness persists or worsens
    • 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

  • PREGNANCY OR BREAST FEEDING

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

  • 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. 1-800-222-1222

  • DOSAGE & ADMINISTRATION

    Directions

    Do not take more than directed

    Adults and children 12 years of age and over:

    allow one lozenge to dissolve slowly in mouth
    may be repeated every 2 hours as needed or as directed by a doctor
    Children under 12 years of age: ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • Contains: SOY
    • 12 calories per drop
    • store at 59° to 86°F (15°-30°C) in a dry place
    • avoid excessive heat and humidity
  • INACTIVE INGREDIENT

    Inactive ingredients 

    corn syrup, eucalyptus oil, FD&C red #40, natural & artificial flavors, soy lecithin, sucrose, water

  • PRINCIPAL DISPLAY PANEL

    TherastatCherry.jpg

  • INGREDIENTS AND APPEARANCE
    THERASTAT, CHERRY 
    cherry cough drops lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0147
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize17mm
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0147-450 in 1 BOX01/09/2023
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0147-7125 in 1 BOX01/09/2023
    21 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:50332-0147-8250 in 1 BOX01/09/2023
    31 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/09/2023
    Labeler - HART Health (069560969)