FDA Label for Medicated Chest
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- ADVERSE REACTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Medicated Chest Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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 ingredientsCamphor 4.8%Eucalyptus oil 1.2%Menthol 2.6%
Otc - Purpose
PurposeCough suppressant + topical analgesicCough suppressantCough suppressant + topical analgesic
Indications & Usage
Uses•on chest + throat, temporarily relieves cough due to the common cold•on muscles and joints, temporarily relieves minor aces and pains
Warnings
WarningsFor external use only; avoid contact with eyes.
Otc - Do Not Use
Do not use•by mouth •with tight bandages •in nostrils •on wounds or damaged skin
Otc - Ask Doctor
Ask a doctor before use if you have•cough that occurs with too much phlegm (mucus)•persistent or chronic cough such as occurs with smoking, asthma or emphusema
Otc - When Using
When using this product do not•heat •microwave •add to hot water or any container when heatingMay cause splattering and result in burns.
Otc - Stop Use
Stop use and ask a doctor if•muscle aches and pains persist more than 7 days or come back•cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.These could be signs of serious condition.
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 Center right away.
Dosage & Administration
DirectionsSee important warnings under "When using this product"•adults + children 2 yrs + over:•rub a thick layer on chest + throat or rub on sore aching muscles•cover with a warm, dry cloth if desired•keep clothing loose about throat/chest to help vapors reach the nose/mouth•repeat up to three times per 24 hours or as directed•children under 2 years of age: ask a doctor
Other Safety Information
Other information •store at room temperature
Inactive Ingredient
Inactive ingredients cedar leaf oil, nutmeg oil, special petrolatum, spirits of turpentine, thymol
Adverse Reactions
DISTRIBUTED BY CARDINAL HEALTHDUBLIN OH 43017www.myleader.com1-800-200-6313
Package Label.Principal Display Panel
LeaderChest RubCough SuppressantTopical AnalgesicNET WT 1.76 oz(50 g)
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