FDA Label for Assured Vaporizing Chest Rub
View Indications, Usage & Precautions
Assured Vaporizing Chest Rub Product Label
The following document was submitted to the FDA by the labeler of this product Greenbrier International, Inc.. 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.
Otc - Active Ingredient
Active ingredients
Camphor 4.7%
Menthol 1.25%
Eucalyptus Oil 1.2%
Otc - Purpose
Purpose
Cough suppressant/topical analgesic
Cough suppressant/topical analgesic
Cough suppressant
Indications & Usage
Uses
Temporarily relieves throat and chest
- cough
- nasal congestion due to common cold
- aching muscles
- minor aches and pains
Warnings
Warnings
For external use only. Avoid contact with eyes.
Otc - Do Not Use
Do not use
- by mouth
- in nostrils
- on wounds or damaged skin
- with tight bandages
Otc - Ask Doctor
Ask a doctor before use if you have
- asthama
- excessive phlegm (mucus)
- emphysema
- persistent or chronic cough
- cough associated with smoking
Otc - When Using
When using this product do not
- heat
- microwave
- use near open flame
- add to hot water or any container where heating water may cause splattering and result in burns
Otc - Stop Use
Stop use and ask a doctor if
- muscle aches/pain persist more than 7 days or come back
- cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious conditions.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Centre right away.
Dosage & Administration
Directions
- see important warnings under "When using this product"
- children under 2 years of age, ask a doctor before using this product
- adults and children 2 years and older, rub a thick layer on chest and throat or rub on sore aching muscles. If desired, cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily.
Other
Other information
- Store at room temperature
Inactive Ingredient
Inactive ingredients
cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL
ASSURED VAPORIZING CHEST RUB
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