CETIRIZINE HYDROCHLORIDE 10 MG 10 mg/1

CETIRIZINE HYDROCHLORIDE · TABLET · SDA Laboratories, Inc.

1 Recall on Record

Plain English

CETIRIZINE HYDROCHLORIDE 10 MG is a tablet containing cetirizine hydrochloride at 10 mg/1, taken oral. Manufactured by SDA Laboratories, Inc..

Key Facts

Brand Name: CETIRIZINE HYDROCHLORIDE 10 MG
Generic Name: CETIRIZINE HYDROCHLORIDE
NDC Code (Product): 66424-564
Manufacturer: SDA Laboratories, Inc.
Strength: 10 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA209274
Marketing Start: 04/27/2021

Recall History

1 Recall on Record

Class III10/05/2021

A-S Medication Solutions LLC.

Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective9,254 reports

pain8,734 reports

fatigue8,577 reports

alopecia7,346 reports

abdominal discomfort7,226 reports

rheumatoid arthritis7,223 reports

systemic lupus erythematosus6,943 reports

pemphigus6,826 reports

off label use6,421 reports

rash6,389 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 sneezing itchy, watery eyes itching of the nose or throat

Dosage & Administration

Directions adults and children 6 years and over take one 10 mg tablet oncedaily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms. adults 65 years and older ask a doctor 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 or to an antihistamine containing hydroxyine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product: drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use

Frequently Asked Questions

What is CETIRIZINE HYDROCHLORIDE 10 MG used for?

CETIRIZINE HYDROCHLORIDE 10 MG contains CETIRIZINE HYDROCHLORIDE. It is a tablet taken oral. Consult your doctor for specific uses.

Is CETIRIZINE HYDROCHLORIDE 10 MG a controlled substance?

CETIRIZINE HYDROCHLORIDE 10 MG is not classified as a controlled substance by the DEA.

What is the generic name for CETIRIZINE HYDROCHLORIDE 10 MG?

The generic name for CETIRIZINE HYDROCHLORIDE 10 MG is CETIRIZINE HYDROCHLORIDE. There are 12 other brand versions of CETIRIZINE HYDROCHLORIDE.

What is the NDC code for CETIRIZINE HYDROCHLORIDE 10 MG 10 mg/1?

The NDC (National Drug Code) for CETIRIZINE HYDROCHLORIDE 10 MG 10 mg/1 is 66424-564, listed by SDA Laboratories, Inc..

Product NDC

66424-564

Package NDC

66424-564-01

Other Cetirizine 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)