Allergy Plus Headache Relief

ACETAMINOPHEN, DIPHENHYDRAMINE HCL ORAL HUMAN OTC DRUG

Allergy Plus Headache Relief is an FDA drug label for the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE HCL manufactured by WALMART INC. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260518.

Generic name
ACETAMINOPHEN, DIPHENHYDRAMINE HCL
Manufacturer
WALMART INC.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
79903-434
Application
M012
Label effective
20260518

About this product

Allergy Plus Headache Relief is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DIPHENHYDRAMINE HCL. It is labelled by WALMART INC. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 79903-434, application M012, label effective 20260518. It is one of 21 FDA drug label records sharing the active ingredient ACETAMINOPHEN, 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.

What it is used for

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

Active ingredients

Active ingredients (in each caplet) Acetaminophen 325 mg Diphenhydramine HCl 25 mg

Indications & Usage

Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes minor aches and pains headache itching of the nose or throat

Dosage & Administration

Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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How products containing ACETAMINOPHEN, DIPHENHYDRAMINE HCL compare

FDA lists 21 drug label records with ACETAMINOPHEN, 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.

Dosage formProductsManufacturerProducts
— — WALMART INC. 3
— — United Natural Foods, Inc. dba UNFI 2
— — Walgreen Company 2
— — Walgreens 2
— — Amazon.com Services LLC 1

Frequently asked questions

What is Allergy Plus Headache Relief used for?
Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes minor aches and pains headache itching of the nose or throat

Who makes Allergy Plus Headache Relief?
WALMART INC. is the labeler of record for Allergy Plus Headache Relief. 21 FDA label records share the active ingredient ACETAMINOPHEN, 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 Allergy Plus Headache Relief 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 Allergy Plus Headache Relief 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 ACETAMINOPHEN, DIPHENHYDRAMINE HCL?
Yes. 21 FDA drug label records list ACETAMINOPHEN, 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 Allergy Plus Headache Relief been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.