PREMIER VALUE VAPOR STEAM (camphor- synthetic liquid

Premier Value Vapor Steam by

Drug Labeling and Warnings

Premier Value Vapor Steam by is a Otc medication manufactured, distributed, or labeled by PHARMACY VALUE ALLIANCE LLC 101668460, Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Camphor 6.2%

Purpose

Cough suppressant

Use

temporarily relieves cough ocurring with a cold

Warnings

For external use only.

Flammable. Keep away from fire or flame.

For steam inhalation only.

Ask a doctor before use if you have

a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

cough that ocurs with too much phlegm (mucus)

When using this product, do not

• heat
• microwave
• use near an open flame
• take by mouth
• direct steam from the vaporizer too close to the face
• 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 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.

If swallowed, get medical help or contact a Poison Control Center right away. In case of eye exposure, flush with water.

Directions

• see important warnings under "When using this product"
• adults & children 2 years & over:
• use 1 tablespoon of solution for each quart of water or 1½ 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
• breathe in the medicated vapors
• use up to three times daily or as directed by a doctor
• children under 2 years: ask a doctor

Other information

• close container tightly and store at room temperature away from heat

Inactive ingredients

alcohol (78%), cedarleaf oil, dimethicone, eucalyptus oil, laureth-7, menthol, nutmeg oil, poloxamer 124

SPL UNCLASSIFIED SECTION

Tamper-evident: do not use if the imprinted seal under the cap is broken or missing.

Keep this carton. It has important information.

PRINCIPAL DISPLAY PANEL

PREMIER VALUE

Compare to the active ingredient in Vicks ® VapoSteam ®*

MEDICATED VAPORIZING STEAM LIQUID

COUGH SUPPRESSANT

CAMPHOR

Liquid Medication for Hot Steam Vaporizers

Increases the acyion of steam for colds
Relieves Cough to Help You Rest

CAUTION: NOT FOR INTERNAL USE

INGREDIENTS AND APPEARANCE

PREMIER VALUE VAPOR STEAM 
camphor (synthetic) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-256
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)	0.623 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CEDAR LEAF OIL (UNII: BJ169U4NLG)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAURETH-7 (UNII: Z95S6G8201)
MENTHOL (UNII: L7T10EIP3A)
NUTMEG OIL (UNII: Z1CLM48948)
POLOXAMER 124 (UNII: 1S66E28KXA)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-256-08	1 in 1 CARTON	07/01/2014
1		236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/02/2011

Labeler - PHARMACY VALUE ALLIANCE LLC 101668460 (101668460)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(68016-256)