Cetirizine 10 mg/1
Cetirizine Hydrochloride · TABLET, FILM COATED · Major Pharmaceuticals
Cetirizine is an antihistamine medication available over-the-counter that helps relieve allergy symptoms such as sneezing, itching, watery eyes, and runny nose. It comes as a 10 mg oral tablet and is commonly used to treat allergic reactions and hay fever.
Key Facts
- Brand Name
- Cetirizine
- Generic Name
- Cetirizine Hydrochloride
- NDC Code (Product)
0904-6717- Manufacturer
- Major Pharmaceuticals
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA078336
- Marketing Start
- 06/29/2018
Recall History
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Caraco Pharmaceutical Laboratories, Ltd.
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Caraco Pharmaceutical Laboratories, Ltd.
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
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).
Taro Pharmaceuticals U.S.A., Inc.
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
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).
JB Chemicals and Pharmaceuticals Ltd
Tablet/Capsules Imprinted with Wrong ID
Sandoz, Inc
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
Dosage & Administration
Directions use only with enclosed dosing cup find right dose on chart below mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.. adults 65 years and older 5 mL once daily; do not take more than 5 mL in 24 hours children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor
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).
Frequently Asked Questions
What is Cetirizine used for?
Cetirizine is an antihistamine medication available over-the-counter that helps relieve allergy symptoms such as sneezing, itching, watery eyes, and runny nose. It comes as a 10 mg oral tablet and is commonly used to treat allergic reactions and hay fever.
Is Cetirizine a controlled substance?
Cetirizine is not classified as a controlled substance by the DEA.
What is the generic name for Cetirizine?
The generic name for Cetirizine is Cetirizine Hydrochloride. There are 12 other brand versions of Cetirizine Hydrochloride.
What is the NDC code for Cetirizine 10 mg/1?
The NDC (National Drug Code) for Cetirizine 10 mg/1 is 0904-6717, listed by Major Pharmaceuticals.
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
- Cetirizine Hydrochloride (Allergy)10 mg/150090-6170
- Good Sense all day allergy10 mg/150090-7065
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)