RITE AID PHARMACY CONGESTION RELIEF VAPORIZING STEAM- vaporizing steam liquid

Rite Aid Pharmacy congestion relief vaporizing steam by

Drug Labeling and Warnings

Rite Aid Pharmacy congestion relief vaporizing steam by is a Otc medication manufactured, distributed, or labeled by Rite Aid Pharmacy, Unipack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Product Label

Carton Label

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

INGREDIENTS AND APPEARANCE

RITE AID PHARMACY CONGESTION RELIEF VAPORIZING STEAM 
vaporizing steam liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0900
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	6.2 g  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)	.001 g  in 118 mL
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)	5.7 g  in 118 mL
LAURETH-7 (UNII: Z95S6G8201)	.5 g  in 118 mL
MENTHOL (UNII: L7T10EIP3A)	5 g  in 118 mL
NUTMEG OIL (UNII: Z1CLM48948)	.05 g  in 118 mL
POLOXAMER 124 (UNII: 1S66E28KXA)	.15 g  in 118 mL
ALCOHOL (UNII: 3K9958V90M)	82.249 g  in 118 mL
CEDAR LEAF OIL (UNII: BJ169U4NLG)	.15 g  in 118 mL

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0900-5	1 in 1 CARTON
1	NDC: 11822-0900-4	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2014

Labeler - Rite Aid Pharmacy (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(11822-0900)