Drugplain

Antihistamine 50 mg/1

Diphenhydramine HCl · CAPSULE · Gendose Pharmaceuticals, LLC

No Recall History
Plain English

Diphenhydramine hydrochloride is an antihistamine used to relieve allergy symptoms, itching, hives, and cold symptoms, and can also be used as a sleep aid. This 50 mg oral capsule is available over the counter without a prescription.

Key Facts

Brand Name
Antihistamine
Generic Name
Diphenhydramine HCl
NDC Code (Product)
77333-231
Manufacturer
Gendose Pharmaceuticals, LLC
Strength
50 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
05/15/2026

Recall History

No Recall History

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 itchy, watery eyes sneezing itching of the nose or throat

Dosage & Administration

Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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 Antihistamine used for?

Diphenhydramine hydrochloride is an antihistamine used to relieve allergy symptoms, itching, hives, and cold symptoms, and can also be used as a sleep aid. This 50 mg oral capsule is available over the counter without a prescription.

Is Antihistamine a controlled substance?

Antihistamine is not classified as a controlled substance by the DEA.

What is the generic name for Antihistamine?

The generic name for Antihistamine is Diphenhydramine HCl. There are 12 other brand versions of Diphenhydramine HCl.

What is the NDC code for Antihistamine 50 mg/1?

The NDC (National Drug Code) for Antihistamine 50 mg/1 is 77333-231, listed by Gendose Pharmaceuticals, LLC.