Label: 12 HOUR ORIGINAL NASAL DECONGESTANT- nasal spray liquid
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- NDC Code(s): 67751-209-01
- Packager: Navajo Manufacturing Company Inc.
- This is a repackaged label.
- Source NDC Code(s): 11527-140
- 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 December 10, 2020
If you are a consumer or patient please visit this version.
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- Active Ingredient
- Uses
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Warnings
Ask a doctor before use if you have
- heart diease
- high blood pressure
- diabetes
- thyiod diease
- trouble urinating due to enlarged rostate gland.
When using this product
- do not use more than directed
- do not use for more than three 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.
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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 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 Dipslay Panel
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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:67751-209(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:67751-209-01 1 in 1 PACKAGE 12/10/2020 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 12/10/2020 Labeler - Navajo Manufacturing Company Inc. (091917799) Registrant - Navajo Manufacturing Company Inc. (136941411) Establishment Name Address ID/FEI Business Operations Navajo Manufacturing Company Inc. 136941411 relabel(67751-209) , repack(67751-209) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 manufacture(67751-209)
