AFRIN NO DRIP NIGHT CHAMOMILE- oxymetazoline hydrochloride spray, metered

Afrin No Drip Night by

Drug Labeling and Warnings

Afrin No Drip Night by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

• Active ingredients: Purpose
• Oxymetazoline hydrochloride 0.05%: Nasal decongestant

Purpose

Uses

Uses

• temporarily relieves nasal congestion due to:
  • common cold
• hay fever
• upper respiratory allergies
• shrinks swollen nasal membranes so you can breathe more

freely

• temporarily relieves sinus congestion and pressure

Warnings

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

When using this product

When using this product

• 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

Stop use and ask a doctor if

Stop use and ask a doctor if symptoms persist

If pregnant or breast-feeding

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

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

• 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

To Use: Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered 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 nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

Other information

Other information

• store between 20º to 25ºC (68º to 77ºF)
• retain carton for future reference on full labeling

Inactive ingredients

Inactive ingredients benzalkonium chloride solution, benzyl alcohol, dibasic sodium phosphate, edetate disodium, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, monobasic sodium phosphate, polyethylene glycol, povidone, purified water

Questions or comments

Questions or comments? 1-800-317-2165

Package label

NEW

Oxymetazoline HCl

Nasal Solution-Nasal Decongestant

Afrin®

NoDrip

Won't drip from nose or down throat

Night

with soothing chamomile scent

PUMP MIST

Instant

Congstion

Relief for a

More Restful

Night

Up to 12

HOUR

RELIEF

Colds · Allergies

#1 Doctor Recommended

Nasal Decongestant Spray

1/2 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

AFRIN NO DRIP NIGHT  CHAMOMILE
oxymetazoline hydrochloride spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-1160
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
POVIDONE (UNII: FZ989GH94E)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-1160-1	0.5 mL in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	07/01/2020	07/01/2020
2	NDC: 11523-1160-2	1 in 1 CARTON	07/01/2020
2		15 mL in 1 BOTTLE, PUMP; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/01/2020

Labeler - Bayer HealthCare LLC. (112117283)