No Drip Nasal Mist Severe Congestion 1 Fl Oz (30ml)

No Drip Nasal Mist Severe Congestion 1 Fl Oz (30ml)
SPL v3
SPL
SPL Set ID 7256e048-ad69-4322-844d-872f05e6fc8a
Route
NASAL
Published
Effective Date 2024-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Polyethylene Glycol 400 Povidone K90 Water Propylene Glycol Sodium Phosphate, Dibasic, Anhydrous Sodium Phosphate, Monobasic, Anhydrous Xanthan Gum Benzalkonium Chloride Benzyl Alcohol Camphor, (-)- Edetate Disodium Eucalyptol Glycerin Menthol, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-05

Description

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal Decongestant


Medication Information

Purpose

Nasal Decongestant

Description

Oxymetazoline hydrochloride 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 so you can breathe more freely
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

Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle rim between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.

Active Ingredient

Oxymetazoline hydrochloride 0.05%

Other Information
  • store at room temperature
Inactive Ingredients

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, glycerin, menthol, microcrystalline cellulose and carboxymethyl cellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

NDC 41226-718-30

*Compare to the active ingredient in Afrin ®No Drip Severe Congestion Pump Mist

No DRIP

NASAL MIST

Nasal Decongestant

Oxymetazoline HCl Nasal Solution

SEVERE CONGESTION

Pump Mist

Up to 12 Hours Relief

Won’t drip from nose or down throat

Fast, Powerful Congestion Relief

For Colds & Allergies

Maximum Strength plus Menthol

1 FL OZ (30 mL)

How to use:

Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING

IMPORTANT:Keep this carton for future reference on full labeling.

Distributed by:

*This product is not manufactured and distributed by Bayer Healthcare LLC, distributor of Afrin ®No Drip Severe Congestion Pump Mist.

When Using This Product
  • do not use more than directed
  • 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
Stop Use and Ask A Doctor If

symptoms persist.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

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
  • temporarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely
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

Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle rim between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.

Active Ingredient (Active ingredient)

Oxymetazoline hydrochloride 0.05%

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, glycerin, menthol, microcrystalline cellulose and carboxymethyl cellulose sodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic, xanthan gum.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

NDC 41226-718-30

*Compare to the active ingredient in Afrin ®No Drip Severe Congestion Pump Mist

No DRIP

NASAL MIST

Nasal Decongestant

Oxymetazoline HCl Nasal Solution

SEVERE CONGESTION

Pump Mist

Up to 12 Hours Relief

Won’t drip from nose or down throat

Fast, Powerful Congestion Relief

For Colds & Allergies

Maximum Strength plus Menthol

1 FL OZ (30 mL)

How to use:

Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Secure cap after use.

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING

IMPORTANT:Keep this carton for future reference on full labeling.

Distributed by:

*This product is not manufactured and distributed by Bayer Healthcare LLC, distributor of Afrin ®No Drip Severe Congestion Pump Mist.

When Using This Product (When using this product)
  • do not use more than directed
  • 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms persist.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 at 1-800-222-1222.

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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