Label: PREFERRED PLUS 12 HOUR NASAL ORIGINAL- oxymetazoline hydrochloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 61715-048-01, 61715-048-02 - Packager: Kinray
- 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 25, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
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When using this product
- Do not use more than directed
- Do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
- Temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
- Use of this container by more than one person may spread infection
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
- Children under 6 years of age: ask a doctor
- To spray, squeeze bottle quickly and firmly. Do not tilt head bacward while spraying. Wipe nozzle clean after use.
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREFERRED PLUS 12 HOUR NASAL ORIGINAL
oxymetazoline hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-048 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE 50 mg in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-048-02 1 in 1 CARTON 1 NDC:61715-048-01 30 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/31/2008 Labeler - Kinray (012574513) Registrant - Lee Pharmaceuticals (056425432) Establishment Name Address ID/FEI Business Operations Kinray 012574513 label(61715-048) Establishment Name Address ID/FEI Business Operations Lee Pharmaceuticals 056425432 pack(61715-048) Establishment Name Address ID/FEI Business Operations Samson Pharmaceuticals 088169581 manufacture(61715-048)
