Topcare childrens allergy 12.5 mg/5mL

Diphenhydramine Hydrochloride · SOLUTION · Topco Associates LLC

No Recall History

Plain English

Topcare childrens allergy is a solution containing diphenhydramine hydrochloride at 12.5 mg/5mL, taken oral. Manufactured by Topco Associates LLC.

Key Facts

Brand Name: Topcare childrens allergy
Generic Name: Diphenhydramine Hydrochloride
NDC Code (Product): 36800-379
Manufacturer: Topco Associates LLC
Strength: 12.5 mg/5mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
Application #: M012
Marketing Start: 12/15/1987

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue8,745 reports

drug ineffective8,660 reports

headache7,599 reports

nausea7,201 reports

off label use7,180 reports

pain6,868 reports

dyspnoea6,701 reports

diarrhoea5,727 reports

arthralgia5,369 reports

pneumonia5,190 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose • itchy, watery eyes

Dosage & Administration

Directions • read the Quick Start Guide for how to: • prime the bottle • use the spray • clean the spray nozzle • shake gently before each use • use this product only once a day • do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER • Week 1 – use 2 sprays in each nostril once daily • Week 2 through 6 months – use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms • After 6 months of daily use – ask your doctor if you can keep using CHILDREN 4 TO 11 YEARS OF AGE • the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. • an adult should supervise use • use 1 spray in each nostril once daily CHILDREN UNDER 4 YEARS OF AGE • do not use

Warnings

Warnings Only for use in the nose. Do not spray into your eyes or mouth. Do not use • in children under 4 years of age • to treat asthma • if you have an injury or surgery to your nose that is not fully healed • if you have ever had an allergic reaction to this product or any of the ingredients Ask a doctor before use if you have or had glaucoma or cataracts Ask a doctor or pharmacist before use if you are taking • medicine for HIV infection (such as ritonavir) • a steroid medicine for asthma, allergies or skin rash • ketoconazole pills (medicine for fungal infection) When using this product • the growth rate of some children may be slower • stinging or sneezing may occur for a few seconds right after use • do not share this bottle with anyone else as this may spread germs • remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if • you have, or come into contact with someone who has, chicken pox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection. • yo…

Frequently Asked Questions

What is Topcare childrens allergy used for?

Topcare childrens allergy contains Diphenhydramine Hydrochloride. It is a solution taken oral. Consult your doctor for specific uses.

Is Topcare childrens allergy a controlled substance?

Topcare childrens allergy is not classified as a controlled substance by the DEA.

What is the generic name for Topcare childrens allergy?

The generic name for Topcare childrens allergy is Diphenhydramine Hydrochloride. There are 11 other brand versions of Diphenhydramine Hydrochloride.

What is the NDC code for Topcare childrens allergy 12.5 mg/5mL?

The NDC (National Drug Code) for Topcare childrens allergy 12.5 mg/5mL is 36800-379, listed by Topco Associates LLC.

Product NDC

36800-379

Package NDC

36800-379-26

Other Diphenhydramine Brands

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

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