Drugplain

childrens cetirizine hydrochloride 5 mg/5mL

Cetirizine HCl · SOLUTION · Preferred Pharmaceuticals Inc.

No Recall History
Plain English

Children's Cetirizine Hydrochloride is an over-the-counter oral antihistamine used to relieve allergy symptoms such as sneezing, runny nose, itchy eyes, and itchy throat. This liquid formulation contains 5 mg of cetirizine per 5 mL and is designed for children.

Key Facts

Brand Name
childrens cetirizine hydrochloride
Generic Name
Cetirizine HCl
NDC Code (Product)
68788-8188
Manufacturer
Preferred Pharmaceuticals Inc.
Strength
5 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA204226
Marketing Start
05/13/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective9,680 reports
fatigue9,152 reports
pain9,098 reports
alopecia7,419 reports
abdominal discomfort7,344 reports
rheumatoid arthritis7,263 reports
systemic lupus erythematosus6,966 reports
pemphigus6,833 reports
off label use6,731 reports
rash6,722 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 childrens cetirizine hydrochloride used for?

Children's Cetirizine Hydrochloride is an over-the-counter oral antihistamine used to relieve allergy symptoms such as sneezing, runny nose, itchy eyes, and itchy throat. This liquid formulation contains 5 mg of cetirizine per 5 mL and is designed for children.

Is childrens cetirizine hydrochloride a controlled substance?

childrens cetirizine hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for childrens cetirizine hydrochloride?

The generic name for childrens cetirizine hydrochloride is Cetirizine HCl. There are 11 other brand versions of Cetirizine HCl.

What is the NDC code for childrens cetirizine hydrochloride 5 mg/5mL?

The NDC (National Drug Code) for childrens cetirizine hydrochloride 5 mg/5mL is 68788-8188, listed by Preferred Pharmaceuticals Inc..

Product NDC

68788-8188

Package NDC

68788-8188-1

Other Cetirizine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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