Label: 12 HOUR ORIGINAL NASAL DECONGESTANT- nasal spray liquid
- NDC Code(s): 11527-140-55
- Packager: Sheffield Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 30, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
- Ask a Doctor before use if you have
-
When using this product
- Do not use more than directed
- do not use for more than three days, Use onyl 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 thna one person may spread infection.
- stop use and ask a doctor if
- PREGNANCY
- Keep out of the reach of children
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DOSAGE & ADMINISTRATION
- Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
- Children under 6 years of age consult a doctor.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.
- Other information
- Inactive Ingredients:
- Principal display panel- Bottle
- Principal display panel -Carton
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INGREDIENTS AND APPEARANCE
12 HOUR ORIGINAL NASAL DECONGESTANT
nasal spray liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11527-140 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 POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) POVIDONE K29/32 (UNII: 390RMW2PEQ) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11527-140-55 1 in 1 CARTON 05/30/2014 1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 05/30/2014 Labeler - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 manufacture(11527-140)