Family Wellness No Drip Nasal Spray 

Family Wellness No Drip Nasal Spray 
SPL v2
SPL
SPL Set ID 0c006b1c-8ab2-4b9c-8738-e7001c1bb47d
Route
NASAL
Published
Effective Date 2023-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (50 mg)
Inactive Ingredients
Benzalkonium Chloride Microcrystalline Cellulose Glycerin Polyethylene Glycol 300 Edetate Disodium Sodium Phosphate, Monobasic Povidone Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-02

Description

Oxymetazoline 0.05%

Purpose

Nasal Decongestant


Medication Information

Purpose

Nasal Decongestant

Description

Oxymetazoline 0.05%

Uses 

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiroty allergies
  • temporarily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely
Warning

Direction
  • 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.
  • 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.
Purpose 

Nasal Decongestant

Active Ingredient 

Oxymetazoline 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, Disodium EDTA, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol 300, Povidone, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

Principal Display Panel 

Family Wellness No Drip Nasal Mist NDC 55319-983-28

Nasal Spray Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 0.5 FLOZ (15ml)

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 Doctor If

 Systoms 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.

Ask Doctor Before Use If You Have 
  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.
Questions Or Comments ?1 800 222 1087


Structured Label Content

Uses 

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • upper respiroty allergies
  • temporarily relieves sinus congestion and pressure
  • Shrinks swollen membranes so you can breathe more freely
Warning

Direction
  • 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.
  • 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.
Purpose 

Nasal Decongestant

Active Ingredient  (Active ingredient )

Oxymetazoline 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, Disodium EDTA, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol 300, Povidone, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

Principal Display Panel 

Family Wellness No Drip Nasal Mist NDC 55319-983-28

Nasal Spray Oxymetazoline HCL 0.05%

12 hour Nasal Spray

Net Wt 0.5 FLOZ (15ml)

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 Doctor If (Stop use and ask Doctor if)

 Systoms 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.

Ask Doctor Before Use If You Have  (Ask Doctor before use if you have )
  • heart diease
  • high blood pressure
  • diabetes
  • thyiod diease
  • trouble urinating due to enlarged rostate gland.
Questions Or Comments ?1 800 222 1087 (Questions or Comments ?1-800-222-1087)


Advanced Ingredient Data


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