OTC Medication Information: 12 Hour Original Nasal Decongestant

12 HOUR ORIGINAL NASAL DECONGESTANT- oxymetazoline hydrochloride liquid
Navajo Manufacturing Company Inc.

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.

Active Ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal Decongestant

Uses

Tempoarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies

Shrinks swollen membranes so you can breathe more freely.

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.

Stop use and ask a doctor if symptoms persist.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

  • store at a controlled room temperature 20°-25°C (68°-77°F)
  • keep card for future reference on full labeling

Inactive ingredients

Benzalkonium Chloride, Disodium EDTA, Disodium Phosphate, Glycerin, PEG-6, Propylene Glycol, PVP, Sodium Phosphate, Water (Purified)

Principal Dipslay Panel

Nasal Spray
(click image for full-size original)

12 HOUR ORIGINAL NASAL DECONGESTANT
nasal spray liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-209(NDC:11527-140)
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE 50 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 300
GLYCERIN
PROPYLENE GLYCOL
DISODIUM EDTA-COPPER
SODIUM PHOSPHATE, MONOBASIC
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
POVIDONE K29/32
BENZALKONIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67751-209-01 1 BOTTLE, SPRAY in 1 PACKAGE contains a BOTTLE, SPRAY
1 30 mL in 1 BOTTLE, SPRAY This package is contained within the PACKAGE (67751-209-01)
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 Operations
Navajo Manufacturing Company Inc. 136941411 relabel (67751-209), repack (67751-209)
Establishment
Name Address ID/FEI Operations
Sheffield Pharmaceuticals LLC 151177797 manufacture (67751-209)

Revised: 12/2020 Navajo Manufacturing Company Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Medication Sections

Medication Information by RSS

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.