Heb Nasal Spray

Heb Nasal Spray
SPL v4
SPL
SPL Set ID 37620f00-e096-1b13-e054-00144ff88e88
Route
NASAL
Published
Effective Date 2016-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Glycerin Water Benzalkonium Chloride Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-06-15

Description

Drug Facts

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Drug Facts

Uses
  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • reduces swelling of nasal passages; shrinks swollen membranes
  • temporarily restores freer breathing through the nose

Section 42229-5

Drug Facts

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 persist

Section 53414-9

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

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 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor

To use Pump

  • shake well before use
  • to open the cap, hold the bottle with one hand, use the other hand to press groved area of cap firmly and turn counter closwise
  • line up the grooved line on the pump
  • to spray, hold with thumb at bottom of the bottle andnozzle between fingers. Before using the first time, prime pump by depressing pump firmly several times.
  • insert tip of nozzle into nostril. Pump 2 or 3 times into each nostril and sniff deeply without tilting head.
  • wipe nozzle clean after each use
  • to close the cap, turn unitl it 'clicks'
Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • store between 20-25°C (68-77°F)
  • retain carton for future reference on full labelling
Inactive Ingredients

benzalkonium chloride, concentrated glycerin, edetate disodium, purified water,

Questions Or Comments?

1-800-883-0085

When Using This Product
  • do not exceed recommended dosage
  • do not use for 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, sneezing, or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection
Principal Display Panel

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Structured Label Content

Uses
  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • sinusitis
  • reduces swelling of nasal passages; shrinks swollen membranes
  • temporarily restores freer breathing through the nose

Section 42229-5 (42229-5)

Drug Facts

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 persist

Section 53414-9 (53414-9)

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

Purpose

Nasal decongestant

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 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • children under 6 years of age: ask a doctor

To use Pump

  • shake well before use
  • to open the cap, hold the bottle with one hand, use the other hand to press groved area of cap firmly and turn counter closwise
  • line up the grooved line on the pump
  • to spray, hold with thumb at bottom of the bottle andnozzle between fingers. Before using the first time, prime pump by depressing pump firmly several times.
  • insert tip of nozzle into nostril. Pump 2 or 3 times into each nostril and sniff deeply without tilting head.
  • wipe nozzle clean after each use
  • to close the cap, turn unitl it 'clicks'
Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • retain carton for future reference on full labelling
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, concentrated glycerin, edetate disodium, purified water,

Questions Or Comments? (Questions or comments?)

1-800-883-0085

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • do not use for 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, sneezing, or an increase in nasal discharge may occur
  • use of this container by more than one person may spread infection
Principal Display Panel (PRINCIPAL DISPLAY PANEL -)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data


Raw Label Data

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