TOPCARE NOSE DROPS- phenylephrine hydrochloride liquid
Topco Associates LLC

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.

----------

Topco 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?

1-888-423-0139

Principal Display Panel

Extra Strength

Nose Drops

Phenylephrine HCl 1.0%

Nasal Decongestant

For Fast Relief of Sinus Congestion and Pressure

Easy to Use & Dispense

Compare to Neo-Synephrine® active ingredient

Nose Drops Carton

TOPCARE NOSE DROPS
phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-390
Route of Administration	NASAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-390-10	1 in 1 CARTON	08/12/2008	09/02/2012
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/12/2008	09/02/2012

Labeler - Topco Associates LLC (006935977)

Revised: 11/2017

Document Id: 651298dd-f757-4585-ac46-027dd18d6bd8

Set id: e6ceb962-8355-4267-b133-2ffa77b16893

Version: 2

Effective Time: 20171110

Topco Associates LLC