FDA.reportPublic FDA data

Rite Aid Pharmacy congestion relief vaporizing steam

Manufacturer
Rite Aid Pharmacy | Unipack, Inc.
Effective date
2021-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:40

Label at a glance#

ProductRite Aid Pharmacy congestion relief vaporizing steam
Active ingredientCAMPHOR (SYNTHETIC)
Label structure14 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation associated with a cold.

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 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 ...

Storage and handling

-Close container tightly and store at room temperature away from heat

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Uses

OTC - PURPOSE SECTION

temporarily relieves cough due to minor throat and bronchial irritation associated with a cold.

Warnings

WARNINGS SECTION

Warnings

For external use only

Flammable:

WARNINGS AND PRECAUTIONS SECTION

Flammable: Keep away from fire or flame.  For steam inhalation only.

Ask a doctor before use, if you have

OTC - ASK DOCTOR SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE 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 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

STORAGE AND HANDLING SECTION

-Close container tightly and store at room temperature away from heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

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 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

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton LabelCarton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-0900-52023-01-30C16284748780-19d75b9cf-e22e-f424-e053-dadaa90a57ceRite-Aid ® Vaporizing Steam 4oz
11822-0900-52021-12-15C16284748780-19d75b9cf-e22e-f424-e053-dadaa90a57ceRite-Aid ® Vaporizing Steam 4oz
11822-0900-52020-01-31C16284748780-19d75b9cf-e22e-f424-e053-dadaa90a57ceRite-Aid ® Vaporizing Steam 4oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0900-4Rite Aid Pharmacy congestion relief vaporizing steam118 mL in 1 BOTTLELIQUID1183
11822-0900-5Rite Aid Pharmacy congestion relief vaporizing steam1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0900RITE AID PHARMACY CONGESTION RELIEF VAPORIZING STEAM (VAPORIZING STEAM) LIQUID [RITE AID PHARMACY]3Legacy NDC, 2 package rows20211216_1e495011-5bda-4072-b38a-a67583e3ea45.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
CEDAR LEAF OILINACTIVE INGREDIENTBJ169U4NLG2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E62
LAURETH-7INACTIVE INGREDIENTZ95S6G82012
MENTHOLINACTIVE INGREDIENTL7T10EIP3A2
NUTMEG OILINACTIVE INGREDIENTZ1CLM489482
POLOXAMER 124INACTIVE INGREDIENT1S66E28KXA2

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-090011822-0900-4, 11822-0900-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
LAURETH-7Z95S6G8201IACT
MENTHOLL7T10EIP3AIACT
NUTMEG OILZ1CLM48948IACT
POLOXAMER 1241S66E28KXAIACT
ALCOHOL3K9958V90MIACT
CEDAR LEAF OILBJ169U4NLGIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 88 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION, CONCENTRATE / ORAL0.5 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AINHALANT / NASAL32 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
POLOXAMER 124POLOXAMER 1241S66E28KXASUSPENSION / ORAL0.09 mg/1mlExact identifier — unii candidate
3 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AMOUTHWASH / BUCCAL0.15 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACONCENTRATE / ORAL0.05 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AJELLY / NASAL32.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET / SUBLINGUAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ADROPS / NASAL40.32 mgExact identifier — unii candidate
24 equally ranked IID candidates
NUTMEG OILNUTMEG OILZ1CLM48948LIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGUM, CHEWING / BUCCAL89 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET / ORAL0.58 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
NUTMEG OILNUTMEG OILZ1CLM48948ELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact identifier — unii candidate
24 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates

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
d3399e94-431c-58c8-e053-2a95a90a9c0f1e495011-5bda-4072-b38a-a67583e3ea452021-12-15WarningsExact identifier
spl id: d3399e94-431c-58c8-e053-2a95a90a9c0f
spl set id: 1e495011-5bda-4072-b38a-a67583e3ea45

Reported adverse events (FAERS/openFDA)#

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