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Topcare Sinus Relief by Topco Associates LLC

Dosage form: spray
Ingredients: OXYMETAZOLINE HYDROCHLORIDE 0.05mg in 100mL
Labeler: Topco Associates LLC
NDC Code: 36800-688

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Topco Sinus Relief Nasal Spray Drug Facts

Active ingredient

Oxymetazoline HCl 0.05%

Purpose

Nasal decongestant

Uses

temporarily relieves nasal congestion due to

  • colds
  • hay fever
  • upper respiratory allergies

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

When using this product
  • do not exceed recommended dosage
  • use of this container by more than one person may spread infection
  • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
  • do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

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. (1-800-222-1222)

Directions

Remove protective cap. Before using for the first time, prime the pump by firmly depressing its rim several times. Hold container with thumb at base and nozzle between first and second fingers. Without tilting your head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and inhale deeply.

adults and children 6 yrs and 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 24 hours.
children 2 to under 6 yrsask a doctor
children under 2 yrsdo not use

Other information
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

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

Questions or comments?

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12 Hour

Sinus Relief

Nasal Spray

Oxymetazoline HCl 0.05%

Nasal Decongestant

Ultra Fine Mist

With Soothing Vapors

Compare to Vicks® Sinex® 12 Hour Ultra Fine Mist active ingredient

Sinus Relief Nasal Spray Carton

TOPCARE SINUS RELIEF 
oxymetazoline hcl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-688
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE0.05 mg  in 100 mL
Packaging
#Item CodePackage Description
1NDC:36800-688-051 BOTTLE, SPRAY (BOTTLE) in 1 CARTON
114.7 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/29/2009
Labeler - Topco Associates LLC (006935977)

Revised: 01/2010
 
Topco Associates LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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