SANATOS LOZENGES (MENTHOL) LOZENGE [PHARMADEL LLC]

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SANATOS LOZENGES (MENTHOL) LOZENGE [PHARMADEL LLC]
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NDC 55758-301-05, 55758-301-25
Set ID 852edba5-ed44-6212-e053-2a91aa0a9e44
Generic Name
Product Class
Product Number
Application Number PART341
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  • Drug Facts

  • Active ingredient & Purposes

    Active ingredients (in each lozenge) Purposes
    Menthol 5.5 mg................................................ Cough suppressant / oral anesthetic

  • Uses

    For the temporary relief of

    • minor irritation and sore throats
    • cough as may occur with a cold
  • Warnings

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

    Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • a cough that is accompanied by excessive phlegm (mucus)

    Stop use and ask a doctor if

    • a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

    Keep out of the reach of children.

  • Directions

    • adult and children 3 to under 12 years of age: allow the lozenge to dissolve one (1) drop slowly in mouth
    • repeat every 2 hours as needed or as directed by doctor
    • children under 3 years of age: consult a doctor
  • Other information

    • store in cool dry place below 77º F
    • protect from heat and light
    • do not use if package is torn or broken
  • Inactive ingredients

    ascorbic acid, citric acid monohydrate, cordia dichotoma fruit, corn syrup, eucalyptus oil, hyssopus officinalis flowering top, greater galangal, justicia adhatoda leaf, licorice, long pepper, natural honey flavor, natural lemon flavor, sucrose.

  • Questions & comments?

    1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

  • Principal Display Panel

    SanaTos®

    Sore Throat Lozenges/Pastillas para el dolor de garganta

    Relieves Cough/Alivia la Tos

    Soothes Sore Throats/Calma Dolor de Garganta

    Honey Lemon Flavor/Sabor Miel y Limón

    5 pouches x 25 Lozenges each/5 bolsas x 25 pastillas cada una

    Sanatos Cough Drop Honey Lemon

  • INGREDIENTS AND APPEARANCE
    SANATOS LOZENGES 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-301
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    JUSTICIA ADHATODA LEAF (UNII: HH159XOV81)  
    HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    GREATER GALANGAL (UNII: 7Y64R856MB)  
    SUCROSE (UNII: C151H8M554)  
    LONG PEPPER (UNII: 2NMG4EA7B1)  
    CORDIA DICHOTOMA FRUIT (UNII: R4RI8646ZR)  
    LICORICE (UNII: 61ZBX54883)  
    HONEY (UNII: Y9H1V576FH)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize17mm
    FlavorLEMON, HONEYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-301-055 in 1 CARTON03/28/2019
    1NDC:55758-301-251 in 1 BAG; Type 0: Not a Combination Product
    2NDC:55758-301-251 in 1 BAG; Type 0: Not a Combination Product03/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/28/2019
    Labeler - Pharmadel LLC (030129680)
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