12 Hour Decongestant Nasal Spray

12 Hour Decongestant Nasal Spray
SPL v6
SPL
SPL Set ID 7f08a97e-efe3-8ccc-e053-2a91aa0a5d79
Route
NASAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 mg)
Inactive Ingredients
Edetic Acid Propylene Glycol Benzalkonium Chloride Sodium Phosphate, Dibasic, Anhydrous Polyethylene Glycol, Unspecified Water Povidone Sodium Phosphate, Monobasic, Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-01

Description

Oxymetazoline HCL 0.05%

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Oxymetazoline HCL 0.05%

Uses

temporarily relieves nasal congestion due to:

- common cold

- hay fever

- upper respiratory allergies

temporarily relieves sinus congestion and pressure

shrinks swollen nasal membranes

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if symptoms presist

Section 50569-3

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

Section 51945-4

NDC 69618-050-51

Reliabel-1 Laboratories

12 Hour Decongestant Nasal Spray

Oxymetazoline HCL

Pump Mist Anti-Drip

Rapid & Powerful

Congestion Relief

12 Hour Relief

1 FL OZ (30 mL)

Section 53414-9

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

Warnings

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

When using this prduct

do not use more than directed

do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

temporary discomfort such as burning, stinging, sneexing, or an increased nasal discharge may occur

use of this container by more than one person may spread infection

Directions

adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril. Not more often than every 10-12 hours. Do not exceed 2 doeses in 24 hours.

children under 6 years of age: ask a doctor.

Instructions for use: Shake well before use. to open, rotate cap to align the marks. Squeeze cap on toh sides in a counter-clockwise turn and pull to remove. To spray, hold bottles with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto bottle.

Active Ingredient

Oxymetazoline HCL 0.05%

Other Information

store between 20º to 25º C (68º to 77º F)

retain carton for future referance on full labeling

Inactive Ingredients

benzalkoium cjloride, dibasic sodium phosphate, edetate disodium dihydrate, monobasic sodium phosphate, polyethylene glycol, propylene glycol, povidone, purified water

Questions Or Comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday


Structured Label Content

Uses

temporarily relieves nasal congestion due to:

- common cold

- hay fever

- upper respiratory allergies

temporarily relieves sinus congestion and pressure

shrinks swollen nasal membranes

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms presist

Section 50569-3 (50569-3)

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

Section 51945-4 (51945-4)

NDC 69618-050-51

Reliabel-1 Laboratories

12 Hour Decongestant Nasal Spray

Oxymetazoline HCL

Pump Mist Anti-Drip

Rapid & Powerful

Congestion Relief

12 Hour Relief

1 FL OZ (30 mL)

Section 53414-9 (53414-9)

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

Purpose

Nasal decongestant

Warnings

Ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

When using this prduct

do not use more than directed

do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

temporary discomfort such as burning, stinging, sneexing, or an increased nasal discharge may occur

use of this container by more than one person may spread infection

Directions

adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril. Not more often than every 10-12 hours. Do not exceed 2 doeses in 24 hours.

children under 6 years of age: ask a doctor.

Instructions for use: Shake well before use. to open, rotate cap to align the marks. Squeeze cap on toh sides in a counter-clockwise turn and pull to remove. To spray, hold bottles with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto bottle.

Active Ingredient (Active ingredient)

Oxymetazoline HCL 0.05%

Other Information (Other information)

store between 20º to 25º C (68º to 77º F)

retain carton for future referance on full labeling

Inactive Ingredients (Inactive ingredients)

benzalkoium cjloride, dibasic sodium phosphate, edetate disodium dihydrate, monobasic sodium phosphate, polyethylene glycol, propylene glycol, povidone, purified water

Questions Or Comments? (Questions or comments?)

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday


Advanced Ingredient Data


Raw Label Data

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