Cetirizine
Cetirizine Hydrochloride · Tablet, Film Coated · Oral
Active ingredient
Active ingredient (in each tablet) Cetirizine HCl 10 mg
Purpose
Purpose Antihistamine
Uses
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
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. 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)
Do not use
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
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
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When using this product
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
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Pregnancy or breast-feeding
If pregnant or breast-feeding:
• if breast-feeding: not recommended
• if pregnant: ask a health professional before use.
Keep out of reach of children
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
Directions 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
Other information
• store between 20-25 ° C (68-77 ° F)
• do not use if printed foil under cap is broken or missing
Inactive ingredients
Inactive ingredients corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin
Questions?
Questions or comments? 1-800-719-9260
Label text from the FDA structured product label by Major Pharmaceuticals (revised Jan 29, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Cetirizine Hydrochloride in 10 products
Cetirizine NDC products (10)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-5510 | Cetirizine Hydrochloride 10 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7594 | Cetirizine Hydrochloride 10 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 71610-123 | Cetirizine Hydrochloride 10 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 72162-2162 | Cetirizine Hydrochloride 10 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 55154-0194 | Cetirizine Hydrochloride 10 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 51316-764 | Cetirizine Hydrochloride 10 mg/1 Tablet | CVS PHARMACY, INC | ANDA |
| 0904-6717 | Cetirizine Hydrochloride 10 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-7510 | Cetirizine Hydrochloride 10 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 51655-194 | Cetirizine Hydrochloride 10 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 83939-0003 | Cetirizine Hydrochloride 10 mg/1 Tablet, Film Coated | VERITYRX, LLC | ANDA |
Cetirizine recalls
- D-0096-2022 Nov 17, 2021 · Class III · Terminated
Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
Frequently asked questions
What is Cetirizine used for?
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
Who makes Cetirizine?
Cetirizine is listed by 8 labelers in the FDA NDC directory, including A-S Medication Solutions, Aphena Pharma Solutions - Tennessee, LLC, Bryant Ranch Prepack, Cardinal Health 107, LLC.
Has Cetirizine been recalled?
The FDA enforcement database lists 1 recall for Cetirizine, most recently D-0096-2022 (class iii): Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.