SANATOS LOZENGES (MENTHOL) LOZENGE [PHARMADEL LLC]

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SANATOS LOZENGES (MENTHOL) LOZENGE [PHARMADEL LLC]
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NDC 55758-303-05, 55758-303-25
Set ID 853ef35c-1d49-5f9d-e053-2a91aa0a49ff
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 orange 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 Gargantas

    Orange Flavor/Sabor a Naranja

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

    Sanatos Lozenges Orange

  • INGREDIENTS AND APPEARANCE
    SANATOS LOZENGES 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-303
    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)  
    CORDIA DICHOTOMA FRUIT (UNII: R4RI8646ZR)  
    LICORICE (UNII: 61ZBX54883)  
    LONG PEPPER (UNII: 2NMG4EA7B1)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize17mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-303-055 in 1 CARTON03/28/2019
    1NDC:55758-303-2525 in 1 BAG; Type 0: Not a Combination Product
    2NDC:55758-303-2525 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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