TOPCARE NASAL FOUR- phenylephrine hydrochloride spray 
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.

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Topco Associates LLC. Nasal Four Drug Facts

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?

1-888-423-0139

Principal Display Panel

TopCare® health

COMPARE TO 4-WAY® FAST ACTING NASAL SPRAY ACTIVE INGREDIENT

FAST ACTING

Nasal Four

NASAL SPRAY

NASAL DECONGESTANT

PHENYLEPHRINE HCl 1%

FAST RELIEF OF:

1 Nasal Congestion

2 Swollen Nasal Membranes

3 Sinus Congestion

4 Sinus Pressure

1 FL OZ (30 mL)

Nasal Four Carton
TOPCARE NASAL FOUR 
phenylephrine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-648
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)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BORIC ACID (UNII: R57ZHV85D4)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-648-101 in 1 CARTON12/10/2002
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 finalpart34112/10/2002
Labeler - Topco Associates LLC (006935977)

Revised: 5/2023
Document Id: ba8a6033-23b7-47f4-ada3-6a9ccf3c036c
Set id: 99bc8829-167b-4cf8-8421-57da369f24cd
Version: 5
Effective Time: 20230531
 
Topco Associates LLC