Label: CETIRIZINE HCL- cetirizine tablet
CETIRIZINE HCL- cetirizine kit

  • NDC Code(s): 72657-128-03, 72657-128-04, 72657-128-08, 72657-128-14, view more
  • Packager: GLENMARK THERAPEUTICS INC., USA
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 21, 2025

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT
    Cetirizine HCl 5 mg - Cetirizine HCl 10 mg
  • PURPOSE
    Antihistamine
  • INDICATIONS & USAGE
    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
  • WARNINGS
    Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine - Ask a doctor before useif you have liver or kidney ...
  • DOSAGE & ADMINISTRATION
    Cetirizine Hydrochloride Tablets, USP 5 mg - adults and children 6 years and over - 1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 ...
  • Other information
    • store between 20°C to 25°C (68°F to 77°F) • do not use of imprinted foil inner seal on bottle is broken or missing. • FDA approved organic impurities test procedure differs from USP
  • INACTIVE INGREDIENT
    colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
  • OTHER SAFETY INFORMATION
    Questions or comments? call toll-free weekdays 9 AM to 5 PM EST at 1 (888) 721-7115 - Manufactured by: Glenmark Pharmaceuticals Limited - Pithampur, Madhya Pradesh 454775, India - Distributed by ...
  • Package/Label Principal Display Panel
    Container label - NDC 72657-129-35 - 10 mg - 365 Tablets
  • Package/Label Principal Display Panel
    NDC 72657-128-35 - 5 mg- 365 Tablets
  • Principal Display Panel
    Carton label - NDC 72657-129-35 - 10 mg - 365 Tablets
  • Principal Display Panel
    NDC 72657-128-35 - 5 mg - 365 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information