Label: VAPOR INHALER- levmetamfetamine nasal decongestant inhalant
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Contains inactivated NDC Code(s)
NDC Code(s): 49781-045-98 - Packager: Cardinal Health (Leader)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 16, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (per inhaler)
- Purpose
- Use for temporary relief of nasal congestion due to:
- Warnings
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When using this product
- do not exceed recommended dosage
- temporary burning, stinging, sneezing, or increased nasal discharge may occur
- use of this container by more than one person may spread infection
- do not use for more than 7 days
- Use only as directed
- frequent or prolonged use may cause nasal congestion to recur or worsen
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
- the product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetamine
- do not use more often than every 2 hours
adults and children 12 years of age and over 2 inhalations in each nostril children 6 to under 12 years of age
(with adult supervision)
1 inhalation in each nostril children under 6 years of age ask a doctor children under 2 years of age do not use - Other Information
- Inactive Ingredients:
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Questions or comments? 1-877-586-7979
TAMPER EVIDENT - USE ONLY IF PERFORATED TUBE LABEL IS INTACT
*This product is not manufactured or distributed by Procter & Gamble, distributor
of Vicks® VapoInhaler®. Vicks® VapoInhaler® is a trademark of Procter & Gamble.
All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund
DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313 CIN 4914057
Made in the USA BCLE01 Rev. 06/13
- PRINCIPAL DISPLAY PANEL - Vapor Inhaler
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INGREDIENTS AND APPEARANCE
VAPOR INHALER
levmetamfetamine nasal decongestant inhalantProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49781-045 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVMETAMFETAMINE (UNII: Y24T9BT2Q2) (LEVMETAMFETAMINE - UNII:Y24T9BT2Q2) LEVMETAMFETAMINE 50 mg Inactive Ingredients Ingredient Name Strength BORNYL ACETATE (UNII: 213431586X) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) LAVENDER OIL (UNII: ZBP1YXW0H8) MENTHOL (UNII: L7T10EIP3A) METHYL SALICYLATE (UNII: LAV5U5022Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49781-045-98 1 in 1 BLISTER PACK 1 198 in 1 INHALER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/01/2014 Labeler - Cardinal Health (Leader) (097537435) Registrant - Aphena Pharma Solutions-New York, LLC (078573647) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions-New York, LLC 078573647 manufacture(49781-045) , pack(49781-045) , label(49781-045)
