Severe Nasal Spray

Severe Nasal Spray
SPL v4
SPL
SPL Set ID 27747a10-8d1d-41c2-80b9-45452f3b9abc
Route
NASAL
Published
Effective Date 2023-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Aloe Vera Leaf Benzalkonium Chloride Edetate Disodium Anhydrous Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Sodium Phosphate, Dibasic, Unspecified Form Sodium Phosphate, Monobasic, Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-15

Description

Drug Facts


Medication Information

Indications and Usage

Uses

temporarily relieves

  • nasal congestion due to a cold, hay fever, or other upper respiratory allergies
  • sinus congestion and pressure
Dosage and Administration

Directions

  • Adults & children 6 years & older (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 2 to under 6 years: ask a doctor.
  • Children under 2 years: do not use.
Description

Drug Facts

Section 44425-7

Other information -do not exceed 25°C

Section 50569-3

Warnings

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
Section 53414-9

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

Section 55105-1

Active ingredient                                                                                                                                              Purpose

Oxymetazoline hydrochloride 0.05% ............................................................................................... Nasal decongestant

Section 55106-9

Drug Facts

Inactive Ingredients

aloe barbadensis leaf extract, benzalkonium chloride, disodium EDTA, polyethylene glycol, PVP, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphste monobasic

Principal Display Panel

SEVERE Nasal Spray

Oxymetazoline HCl 0.05 %

Nasal Decongestant

SUPER-FINE Moisturizing MIST

- Helps relieve sinus congestion & pressure

- Soothing aloe

0.5 FL OZ (15mL)

When Using This Product
  • do not exceed recommended dosage
  • Do not use this product 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 increased nasal discharge may occur
  • use of this container by more than one person may spread infection
Stop Use and Ask A Doctor If
  • symptoms persist
Keep Out of Reach of Children.

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


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves

  • nasal congestion due to a cold, hay fever, or other upper respiratory allergies
  • sinus congestion and pressure
Dosage and Administration (34068-7)

Directions

  • Adults & children 6 years & older (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 2 to under 6 years: ask a doctor.
  • Children under 2 years: do not use.
Section 44425-7 (44425-7)

Other information -do not exceed 25°C

Section 50569-3 (50569-3)

Warnings

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredient                                                                                                                                              Purpose

Oxymetazoline hydrochloride 0.05% ............................................................................................... Nasal decongestant

Section 55106-9 (55106-9)

Drug Facts

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf extract, benzalkonium chloride, disodium EDTA, polyethylene glycol, PVP, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphste monobasic

Principal Display Panel

SEVERE Nasal Spray

Oxymetazoline HCl 0.05 %

Nasal Decongestant

SUPER-FINE Moisturizing MIST

- Helps relieve sinus congestion & pressure

- Soothing aloe

0.5 FL OZ (15mL)

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • Do not use this product 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 increased nasal discharge may occur
  • use of this container by more than one person may spread infection
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms persist
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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