Label: SAINT- cough spray liquid

  • 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 July 21, 2023

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

  • Active ingredient

    Menthol 3.2%

  • Purpose

    Cough Suppressant

  • Use

    To relieve cough, eliminate phlegm, anti-inflammatory, and relieve headache, sore throat, red eyes, throat and lung discomfort symptoms

    Suitable for cough caused by the following diseases:

    Cold, trachea and bronchitis, pulmonary fibrosis, pulmonary sarcoidosis

  • Warnings

    For external use only

    For nebulization inhalation only, do not take orally.

    Please keep this product out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Please keep this product out of the reach of children.

  • Directions

    • see important warnings under "When using this product"
    • adults & children 2 years & over:
    • use 1 tablespoon of solution for each quart of water or 1½ teaspoonful of solution for each pint of water
    • add solution directly to cold water only in a hot steam vaporizer (follow manufacturer's directions for using vaporizer)
    • breathe in the medicated vapors
    • use up to three times daily or as directed by a doctor
    • children under 2 years: ask a doctor
  • When using this product

    • Use as instructed.
    • The persons with a history of allergies should try and observe.
  • Counsult a doctor when using:

    • COPD, or a persistent chronic cough
    • Asthma and emphsema patients
    • Long-term smoking and coughing or cancer patients
    • Patients with severe pulmonary heart disease
    • Pregnant women, lactating women and children under the age of 12.
  • Usage

    This product has been diluted and accurately dosed in accordance with FDA medication recommendations, 5 ml per vial, and it can be used by inhalation in an atomizer, each vial can be used once, 2-3 times a day.

    Choose an atomizer and use it according to the manufacturer's instructions.

    It is recommended to use mesh-sieve atomizer, medical-grade products should be selected, and that is product with medical device approval numbers.

  • Other information:

    The product should be stored strictly away from light and should be kept at low temperature.

    The total amount is 15.22 ounces (150 ml), including 90 vials, 0.1691 ounces (5ml) per vial.

  • Inactive ingredient

    EGCG, Ginsenosides, N-Acetyl Cysteine, Nattokinase, Medical Purified Water

  • PRINCIPAL DISPLAY PANEL

    72784-101-01

    PDP

  • INGREDIENTS AND APPEARANCE
    SAINT 
    cough spray liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72784-101
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)  
    GINSENOSIDES (UNII: 3K198YD54P)  
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    NATTOKINASE (UNII: H81695M5OP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72784-101-0190 in 1 BOX07/20/2023
    15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/20/2023
    Labeler - Saint Medicine, Inc. (081508032)
    Establishment
    NameAddressID/FEIBusiness Operations
    Almil Nutritional Products, Inc.153736301manufacture(72784-101)