CAREONE COLD AND SINUS- phenylephrine hydrochloride solution/ drops 
American Sales Company

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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American Sales Company Cold & Sinus Nose Drops Drug Facts

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)

cold-and-sinus-nose-drops-image
CAREONE COLD AND SINUS 
phenylephrine hydrochloride solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-831
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorYELLOW (Clear to slightly yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-831-101 in 1 CARTON10/20/2016
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/20/2016
Labeler - American Sales Company (809183973)

Revised: 9/2018
Document Id: 0f60cb21-8931-4f02-943f-4fc3d23f6545
Set id: f7b4c55a-f31c-4418-81a1-2f3193f6f9d3
Version: 3
Effective Time: 20180913
 
American Sales Company