NASAL 12 HOUR- oxymetazoline hcl spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)
Available from:
Meijer Distribution Inc
Administration route:
NASAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nasal decongestant
Authorization status:
OTC monograph final
Authorization number:
41250-065-10

NASAL 12 HOUR- oxymetazoline hcl spray

Meijer Distribution 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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Meijer Distribution, Inc. Nasal Spray Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpos e

Nasal decongestant

Us es

Warnings

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

symptoms persist

If pregnant or breast-feeding,

temporarily relieves nasal congestion due to:

common cold

hay fever

upper respiratory allergies

temporarily relieves sinus congestion and pressure

shrinks swollen nasal membranes so you can breathe more freely

heart disease

high blood pressure

diabetes

thyroid disease

trouble urinating due to an enlarged prostate gland

do not use more than directed

do not use for 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

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

To Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and

firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

Other information

Inactive ingredients

benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, glycerin,

monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water

Questions or comments?

1-800-719-9260

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Compare to Afrin® Nasal Spray active ingredient

#1 DOCTOR RECOMMENDED – ADULT NASAL SPRAY ACTIVE INGREDIENT

MAXIMUM STRENGTH

nasal spray

Oxymetazoline HCl

Nasal Decongestant

12 HOUR RELIEF

EXTRA MOISTURIZING

FAST, POWERFUL CONGESTION RELIEF

COLDS - ALLERGIES

HELPS REHYDRATE DRY NASAL PASSAGES

1 FL OZ (30 mL)

adults and children 6 to under 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 doses in any 24-hour period.

children under 6 years of age: ask a doctor

store at 20-25°C (68-77°F)

retain carton for future reference on full labeling

NASAL 12 HOUR

oxymetazoline hcl spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -0 6 5

Route of Administration

NASAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Meijer Distribution Inc

O XYMETAZO LINE HYDRO CHLO RIDE (UNII: K8 9 MJ0 S5VY) (OXYMETAZOLINE -

UNII:8 VLN5B44ZY)

OXYMETAZOLINE

HYDROCHLORIDE

0 .0 5 g

in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM PHO SPHATE, MO NO BASIC (UNII: 39 8 0 JIH2SW)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -0 6 5-10

1 in 1 CARTON

0 5/0 3/19 9 4

1

30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 5/0 3/19 9 4

Labeler -

Meijer Distribution Inc (006959555)

Revised: 4/2019

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