Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae
Route
NASAL
Published
Effective Date 2012-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (7.5 mg)
Inactive Ingredients
Sodium Chloride Sodium Bicarbonate Propylene Glycol Edetate Disodium Benzalkonium Chloride Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-07-15

Description

0.05% Oxymetazoline Hydrochloride


Medication Information

Description

0.05% Oxymetazoline Hydrochloride

Uses

temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies

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.

Box Label

Other Information

Store between 20 to 40 °C (68 to 104 °F)

Retain carton for future reference on full labeling

Active Ingredients

0.05% Oxymetazoline Hydrochloride

Inactive Ingredients

Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water

Directions for Dosing

Adults and children 6 to 12 years of age (with adult supervision): Per dose, 2 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: consult a doctor.

Principal Display Label


Structured Label Content

Uses

temporarily relieves nasal congestion due to: common cold n sinusitis, hay fever, upper respiratory allergies

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.

Box Label (Box label)

Other Information

Store between 20 to 40 °C (68 to 104 °F)

Retain carton for future reference on full labeling

Active Ingredients

0.05% Oxymetazoline Hydrochloride

Inactive Ingredients

Sodium chloride, sodium bicarbonate, propylene glycol, edetate disodium, benzalkonium chloride, purified water

Directions for Dosing

Adults and children 6 to 12 years of age (with adult supervision): Per dose, 2 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: consult a doctor.

Principal Display Label (Principal Display label)


Advanced Ingredient Data


Raw Label Data

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