Pain Reliever PM Extra Strength

Pain Reliever PM Extra Strength is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DIPHENHYDRAMINE HCL. It is labelled by TOP CARE (Topco Associates LLC) taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 36800-466, application M013, label effective 20260901. 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.

Across FDA labelling, products containing ACETAMINOPHEN, DIPHENHYDRAMINE HCL are most often described in connection with: temporary relief, occasional headaches, minor aches, accompanying sleeplessness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

Directions do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours. children under 12 years: do not use

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 in children under 12 years of age 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 trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days 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 (1-800-222-1222) right away: Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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.

What is Pain Reliever PM Extra Strength used for?
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

Who makes Pain Reliever PM Extra Strength?
TOP CARE (Topco Associates LLC) is the labeler of record for Pain Reliever PM Extra Strength. 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 Pain Reliever PM Extra Strength 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 Pain Reliever PM Extra Strength 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 Pain Reliever PM Extra Strength 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.