Drugplain

levocetirizine dihydrochloride .5 mg/mL

Levocetirizine dihydrochloride · SOLUTION · Padagis Israel Pharmaceuticals Ltd

3 Recalls on Record
Plain English

levocetirizine dihydrochloride is a solution containing levocetirizine dihydrochloride at .5 mg/mL, taken oral. Manufactured by Padagis Israel Pharmaceuticals Ltd.

Key Facts

Brand Name
levocetirizine dihydrochloride
Generic Name
Levocetirizine dihydrochloride
NDC Code (Product)
45802-680
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Strength
.5 mg/mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA091263
Marketing Start
11/07/2011

Recall History

3 Recalls on Record
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class III11/11/2020

InvaTech Pharma Solutions, LLC

Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.

TerminatedVoluntary: Firm initiated
Class II02/09/2018

American Pharmaceutical Ingredients LLC

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue337 reports
diarrhoea294 reports
headache280 reports
nausea276 reports
dyspnoea273 reports
pruritus265 reports
drug ineffective237 reports
dizziness211 reports
arthralgia210 reports
fall198 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 respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Dosage & Administration

Directions adults 65 years of age and older ask a doctor adults and children 12-64 years of age take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age take 1/2 tablet (2.5 mg) once daily in the evening do not take more than 1/2 tablet (2.5 mg) in 24 hours children under 6 years of age do not use consumers with kidney disease do not use

Warnings

Warnings Do not use if you have kidney disease if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine Ask a doctor before use if you have ever had trouble urinating or emptying your bladder 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 doctor if you have trouble urinating or emptying your bladder 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 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 levocetirizine dihydrochloride used for?

levocetirizine dihydrochloride contains Levocetirizine dihydrochloride. It is a solution taken oral. Consult your doctor for specific uses.

Is levocetirizine dihydrochloride a controlled substance?

levocetirizine dihydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for levocetirizine dihydrochloride?

The generic name for levocetirizine dihydrochloride is Levocetirizine dihydrochloride. There are 10 other brand versions of Levocetirizine dihydrochloride.

What is the NDC code for levocetirizine dihydrochloride .5 mg/mL?

The NDC (National Drug Code) for levocetirizine dihydrochloride .5 mg/mL is 45802-680, listed by Padagis Israel Pharmaceuticals Ltd.

Product NDC

45802-680

Package NDC

45802-680-28

Other Levocetirizine Brands

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

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