Oxymetazoline Hydrochloride Spray
FDA Label NDC 51672-2030

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Taro Pharmaceuticals U.s.a., Inc. for the product Oxymetazoline Hydrochloride (NDC 51672-2030). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

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)

    Principal Display Panel (30 mL Bottle Carton)

    Principal Display Panel (30 mL Bottle Carton)

* Please review the disclaimer below.