OTC Medication Information: 12 Hour Original Nasal Decongestant

12 HOUR ORIGINAL NASAL DECONGESTANT- oxymetazoline hydrochloride liquid
Preferred Pharmaceuticals 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.

Drug Facts

Active Ingredient
Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal Decongestant

Uses

Tempoarily relieves nasal congestion due to:

common cold
hay fever
sinusitis
upper respiroty allergies
Shribnk swollen membranes so you can breathemore 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 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

symptoms persist.

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.

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 between 20° and 25°C (68° to 77°F)
retain carton for future reference on full labeling

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

Principal display panel- Bottle

Nasal Decongestant 12 Hour Spray
(click image for full-size original)

Lee

Relieves Congestion

Nasal Spray original 12 hour relief

Oxymetazoline HCL Nasal SolutionNasal Decongestant

1 FL OZ (30 ml)

Relabeled By: Preferred Pharmaceuticals Inc.

12 HOUR ORIGINAL NASAL DECONGESTANT
nasal spray liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7075(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, UNSPECIFIED FORM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
POVIDONE K30
BENZALKONIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7075-3 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
1 30 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (68788-7075-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/02/2018
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL (68788-7075)

Revised: 11/2019 Preferred Pharmaceuticals 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.

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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.

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