SINUFRIN PLUS NEILMED- oxymetazoline hydrochloride spray 
NeilMed Pharmaceuticals, Inc.

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.

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Drug Facts

Active Ingredients

0.05% Oxymetazoline Hydrochloride

Warnings

Directions for Dosing

    * Adults and children 6 to 12 years of age (with adult supervision): Per dose, 2 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: consult a doctor

Uses

Temporarily relieves nasal congestion due to common cold, sinus infections, hay fever, upper respiratory allergies.

Other Information

Store between 20 to 40 °C (68 to 104 °F)
Retain carton for future reference on full labeling


Warnings

KEEP OUT OF REACH OF CHILDREN. If Swallowed,get medical help or contact a Poison Control Center right away.

Do not use this product for more than 3 consecutive days.

Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. If symptoms persist, consult a doctor.

Other Information

Warnings

Stop use and ask a doctor if symptoms of nasal congestion persist after 3 days.

Adult males with prostate disease, do not use this product.

Warnings

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

Warnings

This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.
The use of this container by more than one person may spread infection.

Inactive ingredients

Propylene glycol, glycerin, sodium chloride, hyaluronic acid, aloe vera, allantoin, sodium bicarbonate USP, benzalkonium chloride, edetate disodium, purified water

Principle Display

Imag of BottleImage of bottle

Box Label

Box label

uses

temporarily relieves nasal congestion due to:

common cold

sinusitis

hay fever

upper respiratory allergies

SINUFRIN PLUS  NEILMED
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:13709-232
Route of AdministrationNASALDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxymetazoline Hydrochloride (OXYMETAZOLINE) Oxymetazoline Hydrochloride7.5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride 
Propylene Glycol 
Sodium Chloride 
water 
Sodium Bicarbonate 
Glycerin 
Aloe 
Allantoin 
Hydrochloric Acid 
EDETATE DISODIUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-232-0615 mL in 1 BOTTLE
2NDC:13709-232-0515 mL in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/2012
Labeler - NeilMed Pharmaceuticals, Inc. (783557783)
Establishment
NameAddressID/FEIBusiness Operations
NeilMed Pharmaceuticals, Inc.783557783manufacture(13709-232)

Revised: 9/2012
Document Id: c243e7d4-0748-468b-8e25-b914adafdf83
Set id: 99afe6a6-1350-49c6-9347-b7e531e35925
Version: 2
Effective Time: 20120915
 
NeilMed Pharmaceuticals, Inc.