Family Care Nasal Spray Severe Congestion 0.5 Oz 571 Zdp

Family Care Nasal Spray Severe Congestion 0.5 Oz 571 Zdp
SPL v8
SPL
SPL Set ID 6d0f8e9e-0503-522b-e053-2a91aa0aca35
Route
NASAL
Published
Effective Date 2018-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (5 g)
Inactive Ingredients
Sodium Phosphate, Monobasic, Monohydrate Benzalkonium Chloride Eucalyptol Water Benzyl Alcohol Camphor (synthetic) Polysorbate 80 Propylene Glycol Menthol Sodium Phosphate, Dibasic, Anhydrous Edetic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-05-31

Description

Active ingredient                                                            Purpose Oxymetazoline HCl 0.05%...............................................Nasal decongestant


Medication Information

Warnings and Precautions

Warnings Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Indications and Usage

Directions

  • adults and children 6 to 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 does in any 24-hour period.
  • children under 6 years of age: ask a doctor. Shake well before use. Remove safety seal. To open, rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap onto bottle.
Dosage and Administration

Distributed by:

United Exchange Corp

Cypress, CA 90630 USA

1-888-645-8204

Made in China

Description

Active ingredient                                                            Purpose Oxymetazoline HCl 0.05%...............................................Nasal decongestant

Section 44425-7

Other information

  • store between 20° and 25°C (66° and 77°F)
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if symptoms persist

Section 50567-7

When using this product

  • do not use more than directed
  • do not use 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
Section 51727-6

Inactive ingredients benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic monohydrate

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • temprarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely
Section 55106-9

Active ingredient                                                            Purpose

Oxymetazoline HCl 0.05%...............................................Nasal decongestant


Structured Label Content

Indications and Usage (34067-9)

Directions

  • adults and children 6 to 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 does in any 24-hour period.
  • children under 6 years of age: ask a doctor. Shake well before use. Remove safety seal. To open, rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap onto bottle.
Dosage and Administration (34068-7)

Distributed by:

United Exchange Corp

Cypress, CA 90630 USA

1-888-645-8204

Made in China

Warnings and Precautions (34071-1)

Warnings Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Section 44425-7 (44425-7)

Other information

  • store between 20° and 25°C (66° and 77°F)
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist

Section 50567-7 (50567-7)

When using this product

  • do not use more than directed
  • do not use 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
Section 51727-6 (51727-6)

Inactive ingredients benzalkonium chloride, benzyl alcohol, camphor, edetate disodium, eucalyptol, menthol, polysorbate 80, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic monohydrate

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
  • temprarily relieves sinus congestion and pressure
  • shrinks swollen nasal membranes so you can breathe more freely
Section 55106-9 (55106-9)

Active ingredient                                                            Purpose

Oxymetazoline HCl 0.05%...............................................Nasal decongestant


Advanced Ingredient Data


Raw Label Data

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