Antihistamine

Antihistamine is an FDA-registered drug product whose active ingredient is DIPHENHYDRAMINE HCL. It is labelled by Gendose Pharmaceuticals, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 77333-227, application M012, label effective 20260515. It is one of 90 FDA drug label records sharing the active ingredient DIPHENHYDRAMINE HCL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DIPHENHYDRAMINE HCL are most often described in connection with: temporarily relieves, symptoms due, runny nose, hay fever, upper respiratory, sneezing itchy, watery eyes, common cold. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions take every 4 to 6 hours or as directed by a doctor do not take exceed 6 doses in 24 hours adults and children 12 years and older: 1 capsule to 2 capsules children 6 to under 12 years: 1 capsule children under 6 years: do not use this product in children under 6 years of age

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 you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

FDA lists 90 drug label records with DIPHENHYDRAMINE HCL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

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 symptoms due to the common cold: runny nose sneezing

Who makes Antihistamine?
Gendose Pharmaceuticals, LLC is the labeler of record for Antihistamine. 90 FDA label records share the active ingredient DIPHENHYDRAMINE HCL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Antihistamine come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Antihistamine prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DIPHENHYDRAMINE HCL?
Yes. 90 FDA drug label records list DIPHENHYDRAMINE HCL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Antihistamine been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.