Nasal Decongestant Drug Facts

Nasal Decongestant Drug Facts
SPL v2
SPL
SPL Set ID dd196e5a-a791-47ad-aab5-3f2e760f758a
Route
NASAL
Published
Effective Date 2011-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.5 mg)
Inactive Ingredients
Benzalkonium Chloride Sodium Phosphate, Dibasic Anhydrous Edetate Disodium Sodium Phosphate, Monobasic, Monohydrate Polyethylene Glycol 1450 Povidone Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2008-12-11

Description

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Oxymetazoline HCl 0.05%

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.

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.

Active Ingredient

Oxymetazoline HCl 0.05%

Inactive Ingredients

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

Questions? Cal 1-866-923-4914

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel


Structured Label Content

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

Purpose

Nasal decongestant

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.

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.

Active Ingredient (Active ingredient)

Oxymetazoline HCl 0.05%

Inactive Ingredients (Inactive ingredients)

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

Questions? Cal 1-866-923-4914

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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