Otc - Active Ingredient
Active ingredient PurposeCamphor 6.2%.............................Cough Suppressant
Camphor
FDA Label NDC 59779-058
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Camphor (NDC 59779-058). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Active ingredient PurposeCamphor 6.2%..................Cough Suppressant______________________________________Uses temporarily relieves cough due to minor throatand bronchial irritation associated with a cold.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Indications & Usage
Uses - temporarily relieves cough due to minor throatand bronchial irritation associated with a cold.
Warnings
Warnings If pregnant or breastfeeding consult a healthcare professional before use___________________________________________________Flammable Keep away from fire or flame_____________________________________________- for steam inhalation only - do not take by mouth____________________________________________________Ask a doctor before use if you have a persistent orchronic cough such as occurs with smoking, asthma, oremphysema, or if cough is accompanied by excessivephlegm (mucus)_____________________________________________________When using this product do not- heat - microwave - use near an open flame- add to hot water or any container where heatingwater except when adding to cold water only in a hot steam vaporizer. May cause splattering andresult in burns______________________________________________________Stop use and ask a doctor if-cough persists for more than one (1) week, tends torecur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition______________________________________________________Keep out of reach of children. If swallowed, getmedical help or contact a Poison Control Centerimmediately______________________________________________________
Dosage & Administration
Directions- See Important warnings under "When using this product"- Adults and children 2 years and older: use 1 tablespoon of solution directly for each quart of water or 1-1/2 teaspoonful 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 - Breath in medicated vapors - use up to 3 times daily or as directed by a doctor- For use with children under 2 years of age: ask a doctor________________________________Other information - Close container tightly andstore at room temperature away from heat
Inactive Ingredient
Inactive Ingredients Dimethicone, Eucalyptus Globulus (Encalyptus Oil) Leaf Oil, Laureth-7, Menthol,Mys=ristica Fragrans (nutmeg) Kernal Oil, Poloxarner 124,SD Alcohol 40-B, Thuja Occidentalis (Cedar Leaf) Oil,Lavandula Angustifolia (Lavender) Oil
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