Label: SAINT- cough spray liquid
- NDC Code(s): 72784-101-01
- Packager: Saint Medicine, Inc.
- Category: HUMAN OTC DRUG LABEL
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
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
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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
- Counsult a doctor when using:
-
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:
- Inactive ingredient
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SAINT
cough spray liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72784-101 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.2 g in 100 mL Inactive Ingredients Ingredient Name Strength EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL) GINSENOSIDES (UNII: 3K198YD54P) ACETYLCYSTEINE (UNII: WYQ7N0BPYC) NATTOKINASE (UNII: H81695M5OP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72784-101-01 90 in 1 BOX 07/20/2023 1 5 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/20/2023 Labeler - Saint Medicine, Inc. (081508032) Establishment Name Address ID/FEI Business Operations Almil Nutritional Products, Inc. 153736301 manufacture(72784-101)