Antihistamine

Diphenhydramine HCl · Capsule · Oral

Over the counter Histamine-1 Receptor Antagonist

Active ingredient

Active ingredient (in each banded capsule) Diphenhydramine Hydrochloride 50 mg Purpose Antihistamine

Purpose

Purpose Antihistamine

Uses

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 symptons due to common cold: runny nose sneezing

Warnings

Warnings

Do not use

Do not use With any other product containing diphenhydramine, even one used on skin to make a child sleepy

Ask a doctor before use

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children

Pregnancy or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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) immediately.

Directions

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

Other information

Other information Store at 20° - 25° C (68 - 77 °F)

Inactive ingredients

Inactive ingredients black iron oxide, D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate

Questions?

Questions or comments? Call 1-888-676-7161

Label text from the FDA structured product label by Gendose Pharmaceuticals, LLC (revised May 15, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Antihistamine NDC products (2)

NDCStrength & formLabelerType
77333-227Diphenhydramine Hydrochloride 25 mg/1
Capsule
Gendose Pharmaceuticals, LLCOTC MONOGRAPH DRUG
77333-231Diphenhydramine Hydrochloride 50 mg/1
Capsule
Gendose Pharmaceuticals, LLCOTC MONOGRAPH DRUG

Frequently asked questions

What is Antihistamine used for?

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 symptons due to common cold: runny nose sneezing

Who makes Antihistamine?

Antihistamine is listed by 1 labeler in the FDA NDC directory, including Gendose Pharmaceuticals, LLC.