Sheffield 12hr Nasal Spray

Drug Facts

Composition & Product

Active Ingredients

Oxymetazoline (50 mg)

Inactive Ingredients

Polyethylene Glycol 300 Glycerin Propylene Glycol Disodium Edta-copper Sodium Phosphate, Monobasic Sodium Phosphate, Dibasic, Anhydrous Povidone K29/32 Benzalkonium Chloride Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-05-30

Medication Information

Purpose

Nasal Decongestant

Dosage and Administration

Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more 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.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.

Description

Active Ingredient Oxymetazoline Hydrochloride 0.05%

Uses

Tempoarily relieves nasal congestion due to:

common cold
hay fever
sinusitis
upper respiroty allergies
Shribnk swollen membranes so you can breathemore freely

Section 42228-7

ask a health professional before use.

Drug Facts

Active Ingredient

Oxymetazoline Hydrochloride 0.05%

Other Information

store between 20° and 25°C (68° to 77°F)
retain carton for future reference on full labeling

Inactive Ingredients:

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

When Using This Product

Do not use more than directed
do not use for more than three days, Use onyl as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
temporary discomfort such as burning ,stinging, sneezing or an increase in nasal discharge may occur.
use of this container by more thna one person may spread infection.

Stop Use and Ask A Doctor if

symptoms persist.

Principal Display Panel Carton

Sheffield Pharmaceuticals NDC 11527-140-55

Original Nasal Spray

Oxymetazoline HCL 0.05%

12 hour relief of Nasal congestion due to:

common cold
hay fever
sinusititus
upper respiratory allerigies

30 mL (1.01 FL OZ)

Principal Display Panel Bottle

Sheffield Pharmaceutical NDC 11527-140-55

Original Nasal Spray

Oxymetazoline HCL 0.05%

12hour relief of Nasal congestion due to:

common cold
hay fever
sinusitis
upper respiratory allergies

30 mL (1.01 FL OZ)

Keep Out of the Reach of Children

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

Ask A Doctor Before Use If You Have

heart diease
high blood pressure
diabetes
thyiod diease
trouble urinating due to enlarged rostate gland.

Principal Display Panel Bottle Back Label

Structured Label Content

Uses

Tempoarily relieves nasal congestion due to:

common cold
hay fever
sinusitis
upper respiroty allergies
Shribnk swollen membranes so you can breathemore freely

Dosage and Administration (34068-7)

Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more 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.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.

Section 42228-7 (42228-7)

ask a health professional before use.

Purpose

Nasal Decongestant

Drug Facts

Active Ingredient

Oxymetazoline Hydrochloride 0.05%

Other Information (Other information)

store between 20° and 25°C (68° to 77°F)
retain carton for future reference on full labeling

Inactive Ingredients:

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

When Using This Product (When using this product)

Do not use more than directed
do not use for more than three days, Use onyl as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
temporary discomfort such as burning ,stinging, sneezing or an increase in nasal discharge may occur.
use of this container by more thna one person may spread infection.

Stop Use and Ask A Doctor if (stop use and ask a doctor if)

symptoms persist.

Principal Display Panel Carton (Principal display panel -Carton)

Sheffield Pharmaceuticals NDC 11527-140-55

Original Nasal Spray

Oxymetazoline HCL 0.05%

12 hour relief of Nasal congestion due to:

common cold
hay fever
sinusititus
upper respiratory allerigies

30 mL (1.01 FL OZ)

Principal Display Panel Bottle (Principal display panel- Bottle)

Sheffield Pharmaceutical NDC 11527-140-55

Original Nasal Spray

Oxymetazoline HCL 0.05%

12hour relief of Nasal congestion due to:

common cold
hay fever
sinusitis
upper respiratory allergies

30 mL (1.01 FL OZ)

Keep Out of the Reach of Children (Keep out of the reach of children)

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

Ask A Doctor Before Use If You Have (Ask a Doctor before use if you have)

heart diease
high blood pressure
diabetes
thyiod diease
trouble urinating due to enlarged rostate gland.

Principal Display Panel Bottle Back Label (Principal display panel- Bottle back label)

Advanced Ingredient Data

[{"name": "OXYMETAZOLINE", "unii": "8VLN5B44ZY", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POLYETHYLENE GLYCOL 300", "unii": "5655G9Y8AQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DISODIUM EDTA-COPPER", "unii": "6V475AX06U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC", "unii": "3980JIH2SW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K29/32", "unii": "390RMW2PEQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

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Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information