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| Product NDC Code | 25000-219 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Cetirizine hydrochloride tablets, 5 mg |
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| Type | Brand | ||||||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | TABLET | ||||||||
| RxCUI drug identifier | 1014676, 1014678 |
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| Application Number | ANDA078933 | ||||||||
| Labeler Name | MARKSANS PHARMA LIMITED | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) For 5 mg: Cetirizine HCl USP 5 mg For 10 mg: Cetirizine HCl USP 10 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours adults 65 years and ove r 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For 10 mg: adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
| 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours | |
| 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. | |
| ask a doctor | |
| ask a doctor |
| one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. | |
| ask a doctor | |
| ask a doctor | |
| ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide Questions? Call at 1-877-376-4271
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Cetirizine Hydrochloride Tablets, 5 mg Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE STARCH, CORN POVIDONE K30 MAGNESIUM STEARATE HYPROMELLOSES POLYETHYLENE GLYCOL TITANIUM DIOXIDE white to off white Rounded-off rectangular shaped J219 Cetirizine Hydrochloride Tablets, 10 mg Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE STARCH, CORN POVIDONE K30 MAGNESIUM STEARATE HYPROMELLOSES POLYETHYLENE GLYCOL TITANIUM DIOXIDE white to off white Rounded-off rectangular shaped J220
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL NDC 25000-219-03 Cetirizine Hydrochloride Tablets USP, 5 mg 30s count bottle label NDC 25000-219-03 Cetirizine Hydrochloride Tablets USP, 5 mg 30s count carton label NDC 25000-219-08 Cetirizine Hydrochloride Tablets USP, 5 mg 100s count bottle label NDC 25000-219-08 Cetirizine Hydrochloride Tablets USP, 5 mg 100s count carton label NDC 25000-219-14 Cetirizine Hydrochloride Tablets USP, 5 mg 1000s count bottle label NDC 25000-220-03 Cetirizine Hydrochloride Tablets USP, 10 mg 30s count bottle label NDC 25000-220-03 Cetirizine Hydrochloride Tablets USP, 10 mg 30s count carton label NDC 25000-220-08 Cetirizine Hydrochloride Tablets USP, 10 mg 100s count bottle label NDC 25000-220-08 Cetirizine Hydrochloride Tablets USP, 10 mg 100s count carton label NDC 25000-220-14 Cetirizine Hydrochloride Tablets USP, 10 mg 1000s count bottle label NDC 25000-220-78 Cetirizine Hydrochloride Tablets USP, 10 mg 7s count carton label NDC 25000-220-81 Cetirizine Hydrochloride Tablets USP, 10 mg 14s count carton label cetirizine-hcl-5-mg-30ct-bottle cetirizine-hcl-5-mg-30ct-ifc cetirizine-hcl-5-mg-100ct-bottle cetirizine-hcl-5-mg-100ct-ifc cetirizine-hcl-5-mg-1000ct-bottle 10mg-30sbottle cetirizine-hcl-10-mg-30s-ifc 10mg-100sbottle cetirizine-hcl-10-mg-100ct-ifc cetirizine-hcl-10-mg-1000s-label cetirizine-hcl-10-mg-7s-ifc cetirizine-hcl-10-mg-14s-ifc
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information •store between 20° to 25°C (68° to 77°F) •do not use if foil seal under cap is broken or missing
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API