Oxymetazoline Hydrochloride 12-Hour

Dosage form: spray
Ingredients: Oxymetazoline Hydrochloride 0.05g in 100mL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
NDC Code: 51672-2030

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.

Oxymetazoline Hydrochloride
Nasal Decongestant 12-Hour Spray

Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses
  • temporary relief of nasal congestion
    • due to the common cold
    • due to hay fever or other upper respiratory allergies
    • associated with sinusitis
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose

Warnings

Do not exceed recommended dosage

This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.

Do not use
  • for more than 3 days

Ask a doctor before use if you have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

When using this product
  • frequent or prolonged use may cause nasal congestion to recur or worsen

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 under 12 years of age (with supervision): 2 to 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 spray: squeeze the bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Inactive ingredients

benzalkonium chloride, dibasic sodium phosphate (anhydrous), edetate disodium (dihydrate), monobasic sodium phosphate (monohydrate), polyethylene glycol 1450, povidone, propylene glycol, purified water.

Questions?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

Compare to the
active ingredient
in Afrin ®*

Nasal
Decongestant
12- Hour Spray

Oxymetazoline
Hydrochloride 0.05%

Maximum Strength

  • Fast Acting
  • Up To 12 Hours Relief

Contains the Active Ingredient
Recommended Most by
Physicians and Pharmacists

12

1 fl oz (30 mL)

OXYMETAZOLINE HYDROCHLORIDE   12-HOUR
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2030
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxymetazoline Hydrochloride (Oxymetazoline) Oxymetazoline0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
benzalkonium chloride 
sodium phosphate, dibasic, anhydrous 
edetate disodium 
sodium phosphate, monobasic, monohydrate 
polyethylene glycol 1450 
povidone 
propylene glycol 
water 
Packaging
#Item CodePackage Description
1NDC:51672-2030-51 BOTTLE, SPRAY in 1 CARTON
115 mL in 1 BOTTLE, SPRAY
2NDC:51672-2030-31 BOTTLE, SPRAY in 1 CARTON
230 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/25/2006
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIOperations
Applied Laboratories, Inc.117337220MANUFACTURE(51672-2030)

Revised: 06/2012
 
Taro Pharmaceuticals U.S.A., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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