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  5. Label Information: Oxymetazoline Hydrochloride 12-hour

FDA Label for Oxymetazoline Hydrochloride 12-hour

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL - 30 ML BOTTLE CARTON

Oxymetazoline Hydrochloride 12-hour Product Label

The following document was submitted to the FDA by the labeler of this product Taro Pharmaceuticals U.s.a., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

* Please review the disclaimer below.