family wellness nasal spray sinus severe

family wellness nasal spray sinus severe
SPL v3
SPL
SPL Set ID 13237d31-c60a-49f8-9b96-4414cf766a08
Route
nasal
Published
Effective Date 2023-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
oxymetazoline (50 mg)
Inactive Ingredients
benzalkonium chloride benzyl alcohol citric acid acetate edetate disodium anhydrous polysorbate 80 sodium citrate sorbitol water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-09-30

Purpose

Nasal Decongestant

Description

Active Ingredient Oxymetazoline Hydrochloride 0.05%


Medication Information

Uses

Tempoarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respirtory allergies
  • temporaily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely
Purpose

Nasal Decongestant

Description

Active Ingredient Oxymetazoline Hydrochloride 0.05%

Drug Facts

Active Ingredient

Oxymetazoline Hydrochloride 0.05%

Warnings 

Directions 
  • 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.
  • Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.

    Wipe nozzle clean after use.
Other Information 
  • store between 20° and 25°C (68° to 77°F)
  • retain carton for future reference on full labeling
Inactive Ingredients 

Benzalkonium Chloride, Benzyl Alcohol, Citric Acid Anhydrous, Disodium EDTA, Fragrance, Polysorbate 80, Sodium Citrate, Sorbitol, Water (Purified)

When Using This Product 
  • Do not use more than directed
  • do not use for more than three 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 the Reach of Children

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

Principal Display Panel Bottle 

Family Wellness                  NDC 55319-827-30

Severe Nasal Spray 

Oxymetazoline HCL 0.05%

Nasal Decongestant 

1.0 FLOZ (30ml)

Principal Display Panel Carton 

Family Wellness NDC 55319-827-30

Severe Nasal Spray

Oxymetazoline HCL 0.05%

Nasal Decongestant

1.0 FLOZ (30ml)

Ask A Doctor Before Use If You Have
  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.

Structured Label Content

Uses

Tempoarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respirtory allergies
  • temporaily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely
Purpose

Nasal Decongestant

Drug Facts

Active Ingredient

Oxymetazoline Hydrochloride 0.05%

Warnings 

Directions 
  • 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.
  • Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.

    Wipe nozzle clean after use.
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, Benzyl Alcohol, Citric Acid Anhydrous, Disodium EDTA, Fragrance, Polysorbate 80, Sodium Citrate, Sorbitol, Water (Purified)

When Using This Product  (When using this product )
  • Do not use more than directed
  • do not use for more than three 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 the Reach of Children (Keep out of the reach of children)

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

Principal Display Panel Bottle  (Principal Display Panel- Bottle )

Family Wellness                  NDC 55319-827-30

Severe Nasal Spray 

Oxymetazoline HCL 0.05%

Nasal Decongestant 

1.0 FLOZ (30ml)

Principal Display Panel Carton  (Principal Display panel -Carton )

Family Wellness NDC 55319-827-30

Severe Nasal Spray

Oxymetazoline HCL 0.05%

Nasal Decongestant

1.0 FLOZ (30ml)

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.

Advanced Ingredient Data


Raw Label Data

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