Label: LEVMETAMFETAMINE inhalant
- NDC Code(s): 79481-0300-1
- Packager: Meijer, Inc.
- 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 July 27, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (per inhaler)
- Purpose
- Use
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Warnings
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
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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
- Questions or comments? 1-877-586-7979
- Principal Display Panel - 198 mg Label
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INGREDIENTS AND APPEARANCE
LEVMETAMFETAMINE
levmetamfetamine inhalantProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0300 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:79481-0300-1 1 in 1 BLISTER PACK 09/29/2023 1 198 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/29/2023 Labeler - Meijer, Inc. (006959555) Registrant - Aphena Pharma Solutions - Maryland, LLC (829739833) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Maryland, LLC 829739833 MANUFACTURE(79481-0300)