FDA Label for Rite Aid Pharmacy Congestion Relief Vaporizing Steam

View Indications, Usage & Precautions

Rite Aid Pharmacy Congestion Relief Vaporizing Steam Product Label

The following document was submitted to the FDA by the labeler of this product Rite Aid Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Active Ingredient                                           Purpose
Camphor 6.2%.............................Cough Suppressant


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


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