- Label RSS
Drug Label Info
Safety
- Report Adverse Events
- FDA Safety Recalls
- Presence in Breast Milk
Related Resources
- Medline Plus
- Clinical Trials
- PubMed
- All Citations
- Adverse Effects
- Therapeutic Use
- Pharmacology
- Clinical Trials
- Biochemical Data Summary
More Info For This Drug
- View Labeling Archives
- RxNorm
- Get Label RSS Feed
- View NDC Code(s)NEW!
- NDC Code(s): 36800-648-10
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 31, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
View All Sections
- Active ingredient
Phenylephrine hydrochloride 1%
- Purpose
- 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
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
See AlsoDailyMed - TOPCARE SINUS NASALPHENYLEPHRINE HCl 1%
FAST RELIEF OF:
1 Nasal Congestion
2 Swollen Nasal Membranes
3 Sinus Congestion
4 Sinus Pressure
1 FL OZ (30 mL)
- INGREDIENTS AND APPEARANCE
TOPCARE NASAL FOUR
phenylephrine hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-648 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 1g in100mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BENZYL ALCOHOL (UNII: LKG8494WBH) BORIC ACID (UNII: R57ZHV85D4) SODIUM BORATE (UNII: 91MBZ8H3QO) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-648-10 1 in 1 CARTON 12/10/2002 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 12/10/2002 Labeler -Topco Associates LLC(006935977)
View All Sections
Find additional resources
(also available in the left menu)
Safety
Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk
Related Resources
Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary
More Info on this Drug
View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!
View Labeling Archives for this drug
TOPCARE NASAL FOUR- phenylephrine hydrochloride spray
Number of versions: 5
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Jun 5, 2023 | 5 (current) | download |
| Mar 8, 2021 | 4 | download |
| May 7, 2018 | 3 | download |
| Nov 3, 2016 | 2 | download |
| Oct 9, 2010 | 1 | download |
RxNorm
TOPCARE NASAL FOUR- phenylephrine hydrochloride spray
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 1087043 | phenylephrine HCl 1 % Nasal Spray | PSN |
| 2 | 1087043 | phenylephrine hydrochloride 10 MG/ML Nasal Spray | SCD |
| 3 | 1087043 | phenylephrine hydrochloride 1 % Nasal Spray | SY |
Get Label RSS Feed for this Drug
TOPCARE NASAL FOUR- phenylephrine hydrochloride spray
To receive this label RSS feed
Copy the URL below and paste it into your RSS Reader application.
https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=99bc8829-167b-4cf8-8421-57da369f24cd
To receive all DailyMed Updates for the last seven days
Copy the URL below and paste it into your RSS Reader application.
https://dailymed.nlm.nih.gov/dailymed/rss.cfm
What will I get with the DailyMed RSS feed?
DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.
DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.
How to discontinue the RSS feed
If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader.
Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?
Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels.
We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.
NDC Codes
TOPCARE NASAL FOUR- phenylephrine hydrochloride spray
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 36800-648-10 |
