CAREONE COLD AND SINUS- phenylephrine hydrochloride solution/ drops

CareOne Cold and Sinus by

Drug Labeling and Warnings

CareOne Cold and Sinus 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 1.0%

Purpose

Nasal decongestant

Uses

• temporarily relieves nasal congestion due to:
• common cold
• hay fever
• upper respiratory allergies
• temporarily relieves sinus congestion and pressure
• shrinks swollen membranes so you can breathe more freely
• temporarily restores freer breathing through the nose

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients

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

• 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

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

• use only as directed
• adults and children 12 years of age and older: 2 or 3 drops in each nostril not more often than every 4 hours
• children under 12 years of age: ask a doctor

Other information

• store at 20-25°C (68-77°F)
• Protect from light. Store in outer carton until contents used.

Inactive ingredients

anhydrous citric acid, benzalkonium chloride solution, purified water, sodium chloride, sodium citrate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Neo-Synephrine® Extra Strength

COLD & SINUS NOSE DROPS

Phenylephrine HCl 1.0%

Nasal Decongestant

4hr

Extra Strength

Easy To Use & Dispense

Relieves:

Nasal Congestion

Sinus Congestion

Sinus Pressure

Non-drowsy

Gluten Free

OUR PHARMACISTS RECOMMEND

1 FL OZ (30mL)

INGREDIENTS AND APPEARANCE

CAREONE COLD AND SINUS 
phenylephrine hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-831
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	YELLOW (Clear to slightly yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-831-10	1 in 1 CARTON	10/20/2016
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	10/20/2016

Labeler - American Sales Company (809183973)