equate pain relief pm

ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE ORAL HUMAN OTC DRUG

equate pain relief pm is an FDA drug label for the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE 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 20260505.

Generic name
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Manufacturer
WALMART INC.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
79903-421
Application
M013
Label effective
20260505

About this product

equate pain relief pm is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE. It is labelled by WALMART INC. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 79903-421, application M013, label effective 20260505. It is one of 7 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE. 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 HYDROCHLORIDE are most often described in connection with: temporary relief, occasional minor, accompanying sleeplessness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (in each 30 mL) Acetaminophen 1000 mg Diphenhydramine HCl 50 mg

Indications & Usage

Use • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness

Dosage & Administration

Directions • take only one dose (30 mL) per day (24 hours) • only use the dose cup provided • take only as directed – see Overdose warning adults & children 12 yrs & over 30 mL at bedtime children under 12 yrs do not use

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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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. • in children under 12 years of age • with any other product containing diphenhydramine, even one used on skin • 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 disease • a breathing problem such as emphysema or chronic bronchitis • glaucoma • 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 • avoid alcoholic beverages • drowsiness will occur • do not drive a motor vehicle or operate 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 • new symptoms occur • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

More products with the same ingredient

ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE

Acetaminophen PM

Major Pharmaceuticals View label

Equate Severe Cold Cough and Flu

WALMART INC. View label

Pain Reliever PM

Magno-Humphries, Inc. View label

RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief

Strive Pharmaceuticals Inc. View label

RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM Caplet

Strive Pharmaceuticals Inc. View label

Tylenol PM

Savings Distributors LLC View label

How products containing ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE compare

FDA lists 7 drug label records with ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE 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
— — Strive Pharmaceuticals Inc. 2
— — WALMART INC. 2
— — Magno-Humphries, Inc. 1
— — Major Pharmaceuticals 1
— — Savings Distributors LLC 1

Frequently asked questions

What is equate pain relief pm used for?
Use • for the temporary relief of occasional minor aches and pains with accompanying sleeplessness

Who makes equate pain relief pm?
WALMART INC. is the labeler of record for equate pain relief pm. 7 FDA label records share the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, 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 equate pain relief pm 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 equate pain relief pm 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 HYDROCHLORIDE?
Yes. 7 FDA drug label records list ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE 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 equate pain relief pm 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.