Label: 12 HOUR ORIGINAL NASAL DECONGESTANT- nasal spray liquid
- NDC Code(s): 11527-140-55
- Packager: Sheffield Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
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.
Updated November 18, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Drug Facts
- 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
- Keep out of the reach of children
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
INGREDIENTS AND APPEARANCE
12 HOUR ORIGINAL NASAL DECONGESTANT
nasal spray liquid
Product 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 final part341 05/30/2014 Labeler - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 manufacture(11527-140)