Drugplain

Topcare Nasal .05 g/100mL

Oxymetazoline HCl · SPRAY, METERED · Topco Associates LLC

No Recall History
Plain English

Topcare Nasal is a spray, metered containing oxymetazoline hcl at .05 g/100mL, taken nasal. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
Topcare Nasal
Generic Name
Oxymetazoline HCl
NDC Code (Product)
36800-388
Manufacturer
Topco Associates LLC
Strength
.05 g/100mL
Dosage Form
SPRAY, METERED
Route
NASAL
Marketing Status
Application #
M012
Marketing Start
11/26/2002

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective4,364 reports
off label use3,540 reports
rash2,865 reports
pain2,749 reports
pruritus2,556 reports
fatigue2,438 reports
nausea2,360 reports
condition aggravated2,188 reports
product use in unapproved indication2,098 reports
vomiting1,993 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage & Administration

Directions adults and children 12 years and over • take 2 tablets every 4 to 6 hours • do not take more than 8 tablets in 24 hours children ages 6 to 11 years • take 1 tablet every 4 to 6 hours • do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age

Warnings

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. 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 exceed recommended dosage Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with a fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Frequently Asked Questions

What is Topcare Nasal used for?

Topcare Nasal contains Oxymetazoline HCl. It is a spray, metered taken nasal. Consult your doctor for specific uses.

Is Topcare Nasal a controlled substance?

Topcare Nasal is not classified as a controlled substance by the DEA.

What is the generic name for Topcare Nasal?

The generic name for Topcare Nasal is Oxymetazoline HCl. There are 11 other brand versions of Oxymetazoline HCl.

What is the NDC code for Topcare Nasal .05 g/100mL?

The NDC (National Drug Code) for Topcare Nasal .05 g/100mL is 36800-388, listed by Topco Associates LLC.