Drugplain

CareOne Childrens Allergy Relief 12.5 mg/5mL

Diphenhydramine HCl · SOLUTION · American Sales Company

No Recall History
Plain English

Careone Children's Allergy Relief is an oral liquid antihistamine containing diphenhydramine that helps relieve allergy symptoms such as sneezing, runny nose, and itchy eyes in children. This medication is available over-the-counter without a prescription.

Key Facts

Brand Name
CareOne Childrens Allergy Relief
Generic Name
Diphenhydramine HCl
NDC Code (Product)
41520-632
Manufacturer
American Sales Company
Strength
12.5 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
04/12/2016

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective6,410 reports
fatigue6,055 reports
dyspnoea5,402 reports
nausea5,227 reports
headache5,197 reports
diarrhoea4,536 reports
off label use4,477 reports
pain4,391 reports
dizziness3,802 reports
cough3,579 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 Other information • store between 20° to 25°C (68° to 77°F) • do not use if carton is opened, or if printed neckband is broken or missing • see bottom panel for lot number and expiration date

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.

Frequently Asked Questions

What is CareOne Childrens Allergy Relief used for?

Careone Children's Allergy Relief is an oral liquid antihistamine containing diphenhydramine that helps relieve allergy symptoms such as sneezing, runny nose, and itchy eyes in children. This medication is available over-the-counter without a prescription.

Is CareOne Childrens Allergy Relief a controlled substance?

CareOne Childrens Allergy Relief is not classified as a controlled substance by the DEA.

What is the generic name for CareOne Childrens Allergy Relief?

The generic name for CareOne Childrens Allergy Relief is Diphenhydramine HCl. There are 12 other brand versions of Diphenhydramine HCl.

What is the NDC code for CareOne Childrens Allergy Relief 12.5 mg/5mL?

The NDC (National Drug Code) for CareOne Childrens Allergy Relief 12.5 mg/5mL is 41520-632, listed by American Sales Company.

Product NDC

41520-632

Package NDC

41520-632-26

Other Diphenhydramine Brands

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

Data from openFDA · Public domain (CC0 1.0)