Saint Cough Spray

Manufacturer
Saint Medicine, Inc. | Almil Nutritional Products, Inc.
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:37

Label at a glance#

ProductSaint
Active ingredientMENTHOL
Label structure11 sections

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 3.2%

Purpose

OTC - PURPOSE SECTION

Cough Suppressant

Use

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Please keep this product out of the reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTC - WHEN USING SECTION

  • Use as instructed.
  • The persons with a history of allergies should try and observe.

Counsult a doctor when using:

OTC - ASK DOCTOR SECTION

  • 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

INDICATIONS & USAGE SECTION

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:

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72784-101-01

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72784-101-012024-01-30C16284748780-11030e365-26e3-111a-e063-dadaa90a10e2Saint Cough Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72784-101-01Saint90 in 1 BOXLIQUID902
72784-101-01Saint5 mL in 1 VIALLIQUID52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72784-101SAINT (COUGH SPRAY) LIQUID [SAINT MEDICINE, INC.]22 package rows20250116_00f8f724-87bc-e3f5-e063-6394a90a2eed.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72784-10172784-101-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2bb95e5d-e06b-c456-e063-6394a90ac3f500f8f724-87bc-e3f5-e063-6394a90a2eed2025-01-15WarningsExact identifier
spl id: 2bb95e5d-e06b-c456-e063-6394a90ac3f5
spl set id: 00f8f724-87bc-e3f5-e063-6394a90a2eed

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.