Drugplain

topcare allergy relief 180 mg/1

fexofenadine hydrochloride · TABLET, FILM COATED · Topco Associates LLC

3 Recalls on Record
Plain English

topcare allergy relief is a tablet, film coated containing fexofenadine hydrochloride at 180 mg/1, taken oral. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
topcare allergy relief
Generic Name
fexofenadine hydrochloride
NDC Code (Product)
36800-691
Manufacturer
Topco Associates LLC
Strength
180 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA212971
Marketing Start
08/23/2021

Recall History

3 Recalls on Record
Class II07/27/2021

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

TerminatedVoluntary: Firm initiated
Class II07/27/2021

Perrigo Company PLC

Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.

TerminatedVoluntary: Firm initiated
Class III04/17/2017

P & L Development, LLC

Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective8,712 reports
fatigue8,549 reports
headache7,487 reports
off label use7,101 reports
nausea7,030 reports
pain6,631 reports
dyspnoea6,517 reports
diarrhoea5,638 reports
arthralgia5,103 reports
pneumonia5,049 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

Dosage & Administration

Directions • place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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 allergy relief used for?

topcare allergy relief contains fexofenadine hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is topcare allergy relief a controlled substance?

topcare allergy relief is not classified as a controlled substance by the DEA.

What is the generic name for topcare allergy relief?

The generic name for topcare allergy relief is fexofenadine hydrochloride. There are 11 other brand versions of fexofenadine hydrochloride.

What is the NDC code for topcare allergy relief 180 mg/1?

The NDC (National Drug Code) for topcare allergy relief 180 mg/1 is 36800-691, listed by Topco Associates LLC.

Product NDC

36800-691

Package NDC

36800-691-39

Other Fexofenadine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)