Active Ingredient (In Each Tablet)
For 5 mg:
Cetirizine HCl USP 5 mg
For 10 mg:
Cetirizine HCl USP 10 mg
Cetirizine Hydrochloride Tablets, 10 Mg Tablet
FDA Label NDC 25000-220
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marksans Pharma Limited for the product Cetirizine Hydrochloride Tablets, 10 Mg (NDC 25000-220). 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 (in each tablet), purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
If pregnant or breast-feeding
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)
Directions
For 5 mg:
| 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 |
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 |
Other Information
•store between 20° to 25°C (68° to 77°F)
•do not use if foil seal under cap is broken or missing
Inactive Ingredients
lactose monohydrate, corn starch, povidone, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide
Questions?
Call at 1-877-376-4271
Principal Display Panel
NDC 25000-219-03
Cetirizine Hydrochloride Tablets USP, 5 mg
30s count bottle label
5mg-30sbottle (Cetirizine HCl 5 mg 30s Bottle)
NDC 25000-219-03
Cetirizine Hydrochloride Tablets USP, 5 mg
30s count carton label
5mg-30s-carton (Cetirizine HCl 5 mg 30s Carton)
NDC 25000-219-08
Cetirizine Hydrochloride Tablets USP, 5 mg
100s count bottle label
5mg-100sbottle (Cetirizine HCl 5 mg 100s Bottle)
NDC 25000-219-08
Cetirizine Hydrochloride Tablets USP, 5 mg
100s count carton label
5mg-100s-carton (Cetirizine HCl 5 mg 100s Carton)
NDC 25000-219-14
Cetirizine Hydrochloride Tablets USP, 5 mg
1000s count bottle label
5mg-1000s-bottle (Cetirizine HCl 5 mg 1000s Bottle)
NDC 25000-220-03
Cetirizine Hydrochloride Tablets USP, 10 mg
30s count bottle label
10mg-30sbottle (Cetirizine HCl 10 mg 30s Bottle)
NDC 25000-220-03
Cetirizine Hydrochloride Tablets USP, 10 mg
30s count carton label
10mg-30scarton (Cetirizine HCl 10 mg 30s Carton)
NDC 25000-220-08
Cetirizine Hydrochloride Tablets USP, 10 mg
100s count bottle label
10mg-100sbottle (Cetirizine HCl 10 mg 100s Bottle)
NDC 25000-220-08
Cetirizine Hydrochloride Tablets USP, 10 mg
100s count carton label
10mg-100scarton (Cetirizine HCl 10 mg 100s Carton)
NDC 25000-220-14
Cetirizine Hydrochloride Tablets USP, 10 mg
1000s count bottle label
10mg-1000bottle (Cetirizine HCl 10 mg 1000s Bottle)
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