Drugplain

Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5 mg/1

Cetirizine hydrochloride, Pseudoephedrine hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · Rugby Laboratories

No Recall History
Plain English

Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride is a tablet, film coated, extended release containing cetirizine hydrochloride, pseudoephedrine hydrochloride at 5 mg/1, taken oral. Manufactured by Rugby Laboratories.

Key Facts

Brand Name
Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Generic Name
Cetirizine hydrochloride, Pseudoephedrine hydrochloride
NDC Code (Product)
0536-1279
Manufacturer
Rugby Laboratories
Strength
5 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA210719
Marketing Start
03/09/2020

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective52 reports
alopecia50 reports
pemphigus50 reports
systemic lupus erythematosus50 reports
abdominal discomfort49 reports
pain49 reports
rheumatoid arthritis49 reports
maternal exposure during pregnancy45 reports
fatigue41 reports
glossodynia41 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 • nasal congestion • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose

Dosage & Administration

Directions • do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 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 hydroxyzine. • 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 • thyroid disease • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • 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 • do not use more than directed • 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. • you get nervous, dizzy, or sleepless …

Frequently Asked Questions

What is Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride used for?

Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride contains Cetirizine hydrochloride, Pseudoephedrine hydrochloride. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride a controlled substance?

Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride?

The generic name for Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride is Cetirizine hydrochloride, Pseudoephedrine hydrochloride. There are 11 other brand versions of Cetirizine hydrochloride, Pseudoephedrine hydrochloride.

What is the NDC code for Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5 mg/1?

The NDC (National Drug Code) for Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5 mg/1 is 0536-1279, listed by Rugby Laboratories.

Product NDC

0536-1279

Package NDC

0536-1279-12

Other Cetirizine Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)