Cetirizine Hydrochloride
FDA Label NDC 54868-5855

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Cetirizine Hydrochloride (NDC 54868-5855). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Cetirizine Hydrochloride 5 mg

Purpose

Antihistamine

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

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.

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.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children
6 years and over		1 to 2 tablets once daily depending upon severity of symptoms; do not take more than
2 tablets in 24 hours.
adults 65 years
and over		1 tablet once a day; do not take 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

Other Information

  • store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Questions?

call 1-877-446-3679

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

Package Label.Principal Display Panel

 PRINCIPAL DISPLAY PANEL - 5 mg Hives Relief

NDC 54868-5855-0

Cetirizine Hydrochloride
Tablets 5 mg
antihistamine

24
HOUR

Relief of
ITCHING
Due to Hives

Tamper Evident: do not use if foil seal under cap
is missing, open or broken

Cetirizine Hydrochloride Tablets 5 mg Package Label (5855)

Cetirizine Hydrochloride Tablets 5 mg Package Label (5855)

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