Drugplain

TopCare Childrens All Day Allergy 5 mg/5mL

Cetirizine HCl · SOLUTION · Topco Associates LLC

No Recall History
Plain English

TopCare Childrens All Day Allergy is a solution containing cetirizine hcl at 5 mg/5mL, taken oral. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
TopCare Childrens All Day Allergy
Generic Name
Cetirizine HCl
NDC Code (Product)
36800-475
Manufacturer
Topco Associates LLC
Strength
5 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
ANDA204226
Marketing Start
02/02/2016

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue569 reports
nausea501 reports
headache444 reports
diarrhoea429 reports
dyspnoea428 reports
pruritus374 reports
drug ineffective364 reports
pain364 reports
product dose omission issue343 reports
cough340 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 • sneezing • itchy, watery eyes • 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 over 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 TopCare Childrens All Day Allergy used for?

TopCare Childrens All Day Allergy contains Cetirizine HCl. It is a solution taken oral. Consult your doctor for specific uses.

Is TopCare Childrens All Day Allergy a controlled substance?

TopCare Childrens All Day Allergy is not classified as a controlled substance by the DEA.

What is the generic name for TopCare Childrens All Day Allergy?

The generic name for TopCare Childrens All Day Allergy is Cetirizine HCl. There are 12 other brand versions of Cetirizine HCl.

What is the NDC code for TopCare Childrens All Day Allergy 5 mg/5mL?

The NDC (National Drug Code) for TopCare Childrens All Day Allergy 5 mg/5mL is 36800-475, listed by Topco Associates LLC.