CAREONE FAST ACTING NASAL- phenylephrine hydrochloride spray

CareOne Fast Acting Nasal by

Drug Labeling and Warnings

CareOne Fast Acting Nasal by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Phenylephrine hydrochloride 1%

Purpose

Nasal decongestant

Uses

• temporarily relieves nasal congestion due to:
• common cold
• hay fever
• upper respiratory allergies

Warnings

Ask a doctor before use if you have

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

When using this product

• do not use more than directed
• do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse.
• use only as directed
• 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

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

• adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours
• children under 12 years: ask a doctor
• Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

Other information

• store at 20°-25°C (68°-77°F)

Inactive ingredients

benzalkonium chloride, benzyl alcohol, boric acid, purified water, sodium borate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in 4-Way® Fast Acting Nasal Spray

FAST ACTING NASAL SPRAY

Phenylephrine Hydrochloride 1 %

Nasal Decongestant

4hr

Relieves:

Nasal Congestion

Swollen Nasal Membranes

Sinus Congestion

Sinus Pressure

Gluten Free

OUR PHARMACISTS RECOMMEND

1 FL OZ (30mL)

INGREDIENTS AND APPEARANCE

CAREONE FAST ACTING NASAL 
phenylephrine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-729
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-729-10	1 in 1 CARTON	11/30/2016
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/30/2016

Labeler - American Sales Company (809183973)