Drugplain

Benadryl Allergy EXTRA STRENGTH 50 mg/1

Diphenhydramine Hydrochloride · TABLET, FILM COATED · Kenvue Brands LLC

No Recall History
Plain English

Benadryl Allergy Extra Strength is an over-the-counter antihistamine tablet containing 50 mg of diphenhydramine hydrochloride, used to relieve allergy symptoms such as sneezing, runny nose, and itchy eyes. It works by blocking histamine in the body to reduce allergic reactions.

Key Facts

Brand Name
Benadryl Allergy EXTRA STRENGTH
Generic Name
Diphenhydramine Hydrochloride
NDC Code (Product)
50580-533
Manufacturer
Kenvue Brands LLC
Strength
50 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
07/05/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue3,477 reports
off label use3,147 reports
pain3,111 reports
headache3,110 reports
drug ineffective2,811 reports
infusion related reaction2,770 reports
arthralgia2,704 reports
nausea2,683 reports
nasopharyngitis2,384 reports
pneumonia2,298 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 temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage & Administration

Directions take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours adults and children 12 years and over 1 capsule children under 12 years do not use

Warnings

Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children avoid alcoholic drinks If pregnant or breast-feeding If pregnant or breast-feeding, 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 Benadryl Allergy EXTRA STRENGTH used for?

Benadryl Allergy Extra Strength is an over-the-counter antihistamine tablet containing 50 mg of diphenhydramine hydrochloride, used to relieve allergy symptoms such as sneezing, runny nose, and itchy eyes. It works by blocking histamine in the body to reduce allergic reactions.

Is Benadryl Allergy EXTRA STRENGTH a controlled substance?

Benadryl Allergy EXTRA STRENGTH is not classified as a controlled substance by the DEA.

What is the generic name for Benadryl Allergy EXTRA STRENGTH?

The generic name for Benadryl Allergy EXTRA STRENGTH is Diphenhydramine Hydrochloride. There are 12 other brand versions of Diphenhydramine Hydrochloride.

What is the NDC code for Benadryl Allergy EXTRA STRENGTH 50 mg/1?

The NDC (National Drug Code) for Benadryl Allergy EXTRA STRENGTH 50 mg/1 is 50580-533, listed by Kenvue Brands LLC.

Product NDC

50580-533

Package NDC

50580-533-24

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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)