Cetirizine HCl 10 mg/1
Cetirizine · TABLET · Strategic Sourcing Services LLC
Cetirizine HCl is an antihistamine tablet taken by mouth that helps relieve allergy symptoms like itching, sneezing, and watery eyes. It is available over-the-counter without a prescription.
Key Facts
- Brand Name
- Cetirizine HCl
- Generic Name
- Cetirizine
- NDC Code (Product)
70677-1279- Manufacturer
- Strategic Sourcing Services LLC
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA078427
- Marketing Start
- 03/01/2025
Recall History
P & L Developments, LLC
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Sandoz, Inc
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Aidapak Services, LLC
Labeling: Label Mixup: CETIRIZINE HCL, Tablet, 5 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 300 mg, NDC 00054002125, Pedigree: AD39564_1, EXP: 5/13/2014.
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Perrigo Company PLC
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Sandoz Incorporated
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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
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 tablets (10) in 24 hours. adults 65 years and over 1 tablet (5 mg) once a day; 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 Cetirizine Hydrochloride Tablets, USP 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
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 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)
Frequently Asked Questions
What is Cetirizine HCl used for?
Cetirizine HCl is an antihistamine tablet taken by mouth that helps relieve allergy symptoms like itching, sneezing, and watery eyes. It is available over-the-counter without a prescription.
Is Cetirizine HCl a controlled substance?
Cetirizine HCl is not classified as a controlled substance by the DEA.
What is the generic name for Cetirizine HCl?
The generic name for Cetirizine HCl is Cetirizine. There are 10 other brand versions of Cetirizine.
What is the NDC code for Cetirizine HCl 10 mg/1?
The NDC (National Drug Code) for Cetirizine HCl 10 mg/1 is 70677-1279, listed by Strategic Sourcing Services LLC.
Other Cetirizine HCl Dosages
Other Cetirizine Brands
See all →- cetirizine hydrochloride10 mg/172162-2173
- cetirizine hydrochloride5 mg/5mL72162-2339
- basic care all day allergy10 mg/172288-007
- basic care all day allergy10 mg/172288-980
- ValuMeds 24-Hour Allergy Relief10 mg/182725-1003
- Cetirizine Hydrochloride Oral Solution1 mg/mL83745-185
- Good Sense all day allergy10 mg/10113-9458
- All Day Allergy10 mg/142507-458
- Allergy Relief10 mg/149035-841
- Cetirizine Hydrochloride (Allergy)10 mg/150090-6170
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)