Active Ingredient
Active Ingredient Purpose
Camphor 6.2%.............................Cough Suppressant
Rite Aid Pharmacy Congestion Relief Vaporizing Steam
FDA Label NDC 11822-0900
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Pharmacy for the product Rite Aid Pharmacy Congestion Relief Vaporizing Steam (NDC 11822-0900). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, uses, warnings, flammable:, ask a doctor before use, if you have, when using this product, do not, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
temporarily relieves cough due to minor throat and bronchial irritation associated with a cold.
Warnings
Warnings
For external use only
Flammable:
Flammable: Keep away from fire or flame. For steam inhalation only.
Ask A Doctor Before Use, If You Have
Ask a doctor before use, if you have a persistant or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus)
When Using This Product, Do Not
When using this product, do not -heat -microwave
-use near an open flame -take by mouth
-direct stream from the vaporizer too close to the face
-add to hot water or any container in which you are heating water except when adding to cold water in a hot steam vaporizer. Improper use may cause the mixture to splatter and cause burns.
Stop Use And Ask A Doctor If
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Keep Out Of Reach Of Children.
In case of eye exposure (flush eyes with water); or in case of accidental ingestion, seek medical help or contact a Poison Control Center right away.
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 1-1/2 teaspoons 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 medicated vapors
-may be repeated up to 3 times a day
-Children under 2 years: do not use
-See important warnings under "When using this product"
-Adults & Children 2 years & over: use 1 tablespoon of solution for each quart of water or 1-1/2 teaspoons 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 medicated vapors
-may be repeated up to 3 times a day
-Children under 2 years: do not use
Other Information
-Close container tightly and store at room temperature away from heat
Inactive Ingredients
dimethicone, eucalyptus globulus (eucalyptus oil) leaf oil, laureth-7, menthol, myristica fragrans (nutmeg) kernel oil, poloxamer 124, SD alcohol 40-B, thuja occidentalis (cedar leaf) oil
* Please review the disclaimer below.
