CARE ONE NOSE DROPS- phenylephrine hydrochloride liquid 
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.

----------

American Sales Company Nose Drops Drug Facts

Active ingredient

Phenylephrine hydrochloride 1.0%

Purpose

Nasal decongestant

Uses

•
temporarily relieves nasal congestion:
•
due to common cold
•
due to hay fever or other upper respiratory allergies
•
temporarily relieves stuffy nose
•
helps clear nasal passages; shrinks swollen membranes
•
temporarily restores freer breathing through the nose
•
helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

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 exceed recommended dosage
•
do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse.
•
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.

Directions

•
use only as directed

adults and children 12 years and over

2 or 3 drops in each nostril not more often than every 4 hours

children under 12 years

ask a doctor

Other information

•
store at 20°-25°C (68°-77°F)
•
protect from light

Inactive ingredients

benzalkonium chloride, citric acid, 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

NOSE DROPS

Phenylephrine HCl 1%

NASAL DECONGESTANT

Fast Relief

Easy to use & dispense

Nose Drops Carton Image 1

Nose Drops Carton Image 1

Nose Drops Carton Image 2

Nose Drops Carton Image 1

Nose Drops Carton Image 2

CARE ONE NOSE DROPS 
phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-390
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)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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:41520-390-101 in 1 CARTON06/01/200407/06/2019
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/200407/06/2019
Labeler - American Sales Company (809183973)

Revised: 12/2018
Document Id: 71a1f982-e22b-436c-a902-778bf1ec4bfe
Set id: b45eb1ac-b3fa-464c-9b16-e2df7bcd0df1
Version: 2
Effective Time: 20181214
 
American Sales Company