- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
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 or
chronic cough such as occurs with smoking, asthma, or
emphysema, or if cough is accompanied by excessive
phlegm (mucus)
_____________________________________________________
When using this product do not
- heat - microwave - use near an open flame
- add to hot water or any container where heating
water except when adding to cold water only in a
hot steam vaporizer. May cause splattering and
result in burns
______________________________________________________
Stop use and ask a doctor if
-cough persists for more than one (1) week, tends to
recur, 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, get
medical help or contact a Poison Control Center
immediately
______________________________________________________
-
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 and
store at room temperature away from heat - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CAMPHOR
camphor liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-058 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) 155 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF) EUCALYPTUS OIL (UNII: 2R04ONI662) LAURETH-7 (UNII: Z95S6G8201) MENTHOL (UNII: L7T10EIP3A) NUTMEG OIL (UNII: Z1CLM48948) POLOXAMER 124 (UNII: 1S66E28KXA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-058-01 1 in 1 CARTON 1 237 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/19/2009 Labeler - CVS (062312574) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture