OTC Medication Information: ASSURED NASAL RELIEF ORIGINAL

ASSURED NASAL RELIEF ORIGINAL- oxymetazoline hydrochloride spray
GREENBRIER INTERNATIONAL, 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 Purpose

Oxymetazoline hydrochloride 0.05% …………………………………….Nasal decongestant

Uses

  • temporarily relieved nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • shrinks swollen nasal membranes so you can breathe more freely

Warnings

For external use only

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

When using this product

  • do not use more than directed
  • do not use more than 3 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor. To open, rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to remove. To srapy, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tiliting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto the bottle.

Other information

  • store between 20 o and 25 o C (68 o and 77 o F)
  • retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate hydrate, disodium EDTA, distilled water, monobasic sodium phosphate dihydrtate, PEG 1450, PVP K30

Distributed by:

Greenbrier International, Inc.

500 Volvo Parkway

Chesapeake, VA 23320

Made in Korea

50138
(click image for full-size original)

ASSURED NASAL RELIEF ORIGINAL
oxymetazoline hydrochloride spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-8684
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE 0.05 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
BENZYL ALCOHOL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
EDETATE DISODIUM
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
POLYETHYLENE GLYCOL 1500
POVIDONE K30
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33992-8684-5 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (33992-8684-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/08/2011
Labeler — GREENBRIER INTERNATIONAL, INC. (610322518)

Revised: 06/2019 GREENBRIER INTERNATIONAL, 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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