Principal Display Panel

Principal Display Panel
SPL v5
SPL
SPL Set ID f945e131-f07d-4e15-890b-6035534b8170
Route
NASAL
Published
Effective Date 2019-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Phenylephrine hydrochloride 1%


Medication Information

Indications and Usage

• temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies

Dosage and Administration

• adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours • children under 12 years: ask a doctor • Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Description

Phenylephrine hydrochloride 1%

Section 44425-7

• store at 20°-25°C (68°-77°F)

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9

symptoms persist

Section 50567-7

• do not use more than directed • do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse. • use only as directed • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur • use of this container by more than one person may spread infection

Section 50569-3

• heart disease • diabetes • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland

Section 51727-6

benzalkonium chloride, benzyl alcohol, boric acid, purified water, sodium borate

Section 51945-4

Compare to 4-Way ® Fast Acting active ingredient nasal four Phenylephrine HCl 1% Nasal Decongestant FAST ACTING NASAL SPRAY Fast Relief of: Nasal Congestion, Swollen Nasal Membranes, Sinus Congestion, and Sinus Pressure 1 FL OZ (30 mL)

Section 53413-1

1-800-719-9260

Section 53414-9

ask a health professional before use.

Section 55105-1

Nasal decongestant

Section 55106-9

Phenylephrine hydrochloride 1%


Structured Label Content

Indications and Usage (34067-9)

• temporarily relieves nasal congestion due to: • common cold • hay fever • upper respiratory allergies

Dosage and Administration (34068-7)

• adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours • children under 12 years: ask a doctor • Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Section 44425-7 (44425-7)

• store at 20°-25°C (68°-77°F)

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9 (50566-9)

symptoms persist

Section 50567-7 (50567-7)

• do not use more than directed • do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse. • use only as directed • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur • use of this container by more than one person may spread infection

Section 50569-3 (50569-3)

• heart disease • diabetes • thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland

Section 51727-6 (51727-6)

benzalkonium chloride, benzyl alcohol, boric acid, purified water, sodium borate

Section 51945-4 (51945-4)

Compare to 4-Way ® Fast Acting active ingredient nasal four Phenylephrine HCl 1% Nasal Decongestant FAST ACTING NASAL SPRAY Fast Relief of: Nasal Congestion, Swollen Nasal Membranes, Sinus Congestion, and Sinus Pressure 1 FL OZ (30 mL)

Section 53413-1 (53413-1)

1-800-719-9260

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Nasal decongestant

Section 55106-9 (55106-9)

Phenylephrine hydrochloride 1%


Raw Label Data

All Sections (JSON)