Drugplain

Childrens Allergy 30 mg/5mL

fexofenadine hydrochloride · SUSPENSION · H2-Pharma, LLC

No Recall History
Plain English

Children's Allergy is an over-the-counter oral suspension containing fexofenadine, an antihistamine used to relieve allergy symptoms such as sneezing, itching, watery eyes, and runny nose. It is formulated specifically for children at a strength of 30 mg per 5 mL.

Key Facts

Brand Name
Childrens Allergy
Generic Name
fexofenadine hydrochloride
NDC Code (Product)
61269-527
Manufacturer
H2-Pharma, LLC
Strength
30 mg/5mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
ANDA203330
Marketing Start
07/18/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective17,844 reports
fatigue17,203 reports
pain15,063 reports
off label use13,196 reports
headache12,108 reports
nausea11,102 reports
rash10,703 reports
dyspnoea10,643 reports
arthralgia9,868 reports
rheumatoid arthritis9,478 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 respiratory allergies: ■ sneezing ■ itching of the nose or throat ■ runny nose ■ itchy watery eyes ■temporarily relieves these symptoms due to the common cold: ■ sneezing ■ runny nose

Dosage & Administration

Directions ■ if needed, take every 4-6 hours ■ do not take more than 6 doses in 24-hours children under 4 years of age Do not use children 4 to under 6 years of age Do not use unless directed by a doctor children 6 to under 12 years of age 1 to 2 teaspoonfuls (5 ml to 10 ml)

Warnings

Warnings Do not use ■ with any other product containing diphenhydramine, even one used on skin ■ to make a child sleepy Ask a doctor before use if the child has ■ glaucoma ■ a breathing problem such as chronic bronchitis

Frequently Asked Questions

What is Childrens Allergy used for?

Children's Allergy is an over-the-counter oral suspension containing fexofenadine, an antihistamine used to relieve allergy symptoms such as sneezing, itching, watery eyes, and runny nose. It is formulated specifically for children at a strength of 30 mg per 5 mL.

Is Childrens Allergy a controlled substance?

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

What is the generic name for Childrens Allergy?

The generic name for Childrens Allergy is fexofenadine hydrochloride. There are 12 other brand versions of fexofenadine hydrochloride.

What is the NDC code for Childrens Allergy 30 mg/5mL?

The NDC (National Drug Code) for Childrens Allergy 30 mg/5mL is 61269-527, listed by H2-Pharma, LLC.