advil pm
Pharmaranks rates Advil Pm 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Advil Pm is a combination medicine containing Diphenhydramine Hydrochloride and Ibuprofen.
Diphenhydramine Hydrochloride and Ibuprofen · by Haleon US Holdings
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Diphenhydramine Hydrochloride and Ibuprofen
- Form
- Capsule, Tablet
- Strength
- Diphenhydramine Hydrochloride 25MG; Ibuprofen EQ 200MG Free Acid AND Potassium Salt
- Type
- Over-the-counter (OTC)
- Brand or generic
- Brand-name
- Manufacturer
- Haleon US Holdings
- Half-life
- about 1.8 to 2.0 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.04 per ml — not your price
- FDA application
- NDA021393
What is Advil Pm?
From the FDA label:Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
How to use
Advil Pm is sold in more than one form (Capsule and Tablet), and each is dosed differently. The instructions below come from the FDA label for application NDA021393 — follow the label that came with the product you were actually prescribed.
Directions do not take more than directed adults and children 12 years and over: take 2 capsules at bedtime do not take more than 2 capsules in 24 hours
Warnings
Important safety information
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer unless you have time for a full night's sleep in children under 12 years of age right before or after heart surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke. you are taking a diuretic you have a breathing problem such as emphysema or chronic bronchitis you have glaucoma you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid under a doctor's care for any continuing medical illness taking any other antihistamines taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
How long does Diphenhydramine Hydrochloride and Ibuprofen stay in your body?
The elimination half-life of diphenhydramine hydrochloride and ibuprofen is about 1.8 to 2.0 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label states a single serum half-life of 1.8 to 2.0 hours — it does not split the curve into a distribution and a terminal phase, so this is the elimination figure. Ibuprofen is not a prodrug, and the label names no active metabolite that outlasts the parent: the two major urinary metabolites (metabolite A, a hydroxymethyl-propyl derivative, and metabolite B, a carboxypropyl derivative) are described only as excretion products, and the label notes that excretion is virtually complete 24 hours after the last dose. This label does not report a different half-life for older adults or for people with kidney or liver impairment; it only advises caution in patients 65 and older and in those with impaired renal or hepatic function, so any change in clearance in those groups is not quantified here. This is a pharmacokinetic figure about how fast the drug leaves the blood — it is not a dosing instruction and not a drug-test detection window.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Ibuprofen tablets USP — FDA label, Clinical Pharmacology (DailyMed).
Dosage forms
Capsule and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- How is Advil Pm rated?
- pharmaranks gives Advil Pm a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Advil Pm cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.04 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Advil Pm?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Advil Pm. To pay less, look for a store-brand version with the same active ingredient (Diphenhydramine Hydrochloride and Ibuprofen), which is typically cheaper, and compare unit prices. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Advil Pm?
- Advil Pm is marketed by Haleon US Holdings. You can see Haleon US Holdings's full profile, rating, and other products on pharmaranks.
- Is Advil Pm a brand-name or generic drug?
- Advil Pm is a brand-name product with the active ingredient Diphenhydramine Hydrochloride and Ibuprofen.
- Is Advil Pm available over the counter?
- Yes. Advil Pm is an over-the-counter (OTC) product — you can buy it without a prescription. Follow the label directions and ask a pharmacist if you're unsure whether it's right for you.
- What forms does Advil Pm come in?
- Advil Pm is currently marketed as capsule and tablet, per the FDA's National Drug Code Directory.
- Is Advil Pm FDA-registered?
- Advil Pm is on record with the U.S. FDA under application number NDA021393. You can verify this on its official FDA label.
- Has Advil Pm been recalled by the FDA?
- Advil Pm has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Advil Pm safe?
- There's no single safe-or-not verdict. pharmaranks gives Advil Pm a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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advil pm
72/100