FDA-filed SPL labeling · retrieved through openFDA

Diphenhydramine / Ibuprofen

Diphenhydramine/ibuprofen is an over-the-counter combination medicine that relieves minor aches and pains while helping you fall asleep and stay asleep.

Brand names Ibuprofen PMAdvil PMExchange Select Ibuprofen PMLeader Ibuprofen PMpain relief pm +11 more
Drug class ⓘ Nonsteroidal Anti-inflammatory Drug
OTC Forms 2 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 59 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveNov 27, 2024
Clinical labels in scope ⓘ59
AvailabilityOTC
Earliest approval/marketing year ⓘ2005
FDA-listed product records ⓘ153
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Diphenhydramine / Ibuprofen at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Diphenhydramine/ibuprofen is a short-term, nighttime-only option for people dealing with both minor pain and occasional trouble sleeping at the same time. It is not for sleep alone, and it should not be used for more than a night or two without talking to a doctor. The ibuprofen component carries real risks for your stomach and heart, so use the lowest effective amount and never exceed the labeled dose.
How we write & review this content — our editorial policy →

📖 Diphenhydramine / Ibuprofen: Patient Information Guide

A plain-language walkthrough of Diphenhydramine / Ibuprofen — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Diphenhydramine/ibuprofen combination products are used for one specific situation: occasional sleeplessness that comes along with minor aches and pains.

  • Relief of occasional sleeplessness when associated with minor aches and pains — supported across all products including Advil PM, Amazon Basic Care Ibuprofen PM, Basic Care Ibuprofen PM, Care One Ibuprofen PM, Ibuprofen PM, and Pain Relief PM in both tablet and capsule forms
  • Helps you fall asleep and stay asleep — supported across all products and forms listed above
💊How it's taken▾

All supported products are taken by mouth at bedtime. Adults and children 12 and older take 2 doses (capsules or caplets, depending on the specific product) at bedtime — never more than that in a 24-hour period. Only take this product when you have time for a full night's sleep.

  • Take with food or milk if the medicine upsets your stomach
  • Do not exceed the labeled dose or use for longer than directed
  • If you miss a bedtime dose, skip it — this product is only meant to be taken once at night
🤒Side effects — in detail▾

Drowsiness is expected with this product — that is part of how it works, so plan accordingly.

  • Drowsiness
  • Stomach upset

Serious reactions to act on right away include signs of stomach bleeding (feeling faint, vomiting blood, black or bloody stools, persistent stomach pain), signs of a heart attack or stroke (chest pain, trouble breathing, sudden weakness, slurred speech, leg swelling), or a severe allergic reaction (hives, facial swelling, wheezing, blistering skin). Stop the medicine and get help immediately if any of these occur.

⚠️Warnings & precautions▾
  • Heart attack and stroke risk: Ibuprofen and other NSAIDs (except aspirin) increase the risk of heart attack, heart failure, and stroke — which can be fatal. This risk is higher if you use more than directed or for longer than directed.
  • Stomach bleeding risk: NSAIDs can cause severe stomach bleeding. Your risk is higher if you are 60 or older, have had stomach ulcers, take blood thinners or steroids, use other NSAIDs, or drink 3 or more alcoholic drinks daily.
  • Drowsiness is guaranteed: Do not drive or operate machinery after taking this product. Never take it unless you can get a full night's sleep.
  • Do not combine with other diphenhydramine products — including skin creams or gels — or with other sleep aids or sedatives.
  • Pregnancy: Ibuprofen should not be used at 20 weeks of pregnancy or later unless a doctor specifically directs it, because it can cause problems for the unborn child or complications during delivery.
  • Not for sleep alone: Do not use this product if you have sleeplessness without any pain.
🔀What it interacts with▾

This product can interact with several common drugs and substances — always check with your pharmacist before combining it with anything else.

  • Alcohol — increases stomach bleeding risk and adds to sedation; avoid completely while using this product
  • Blood thinners (anticoagulants) — ibuprofen raises the risk of serious bleeding
  • Steroid drugs — further increase stomach bleeding risk
  • Other NSAIDs (aspirin, naproxen, and others) — do not combine; compounds both stomach and heart risks
  • Aspirin for heart/stroke prevention — ibuprofen may reduce aspirin's protective benefit
  • Diuretics (water pills) — ask a doctor before combining
  • Sedatives or tranquilizers — increased sedation; ask a doctor or pharmacist first
  • Other antihistamines or any diphenhydramine-containing product — do not combine, even topical (skin) products

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Children under 12 — do not use this product
  • Pregnant or breastfeeding — ask a health professional before use; ibuprofen is especially risky at 20 weeks of pregnancy or later
  • Anyone with a known allergy to aspirin or other pain relievers/fever reducers — do not use
  • People with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke — ask a doctor before use
  • People with a history of stomach ulcers, stomach bleeding, or heartburn — ask a doctor before use
  • Adults age 60 and older — at higher risk for stomach bleeding
  • People with glaucoma, an enlarged prostate gland, trouble urinating, emphysema, or chronic bronchitis — ask a doctor before use
  • Anyone scheduled for heart surgery — do not use right before or after surgery
  • People under a doctor's care for any ongoing medical condition — ask a doctor or pharmacist before use
🚑If you take too much▾

In case of overdose, get medical help or contact a Poison Control Center right away. Do not wait for symptoms to appear before seeking help.

📦How to store it▾

store at 20° to 25°C (68° to 77°F) ■ avoid excessive heat above 40°C (104°F) ■ protect from light

📄 Written from Diphenhydramine / Ibuprofen’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Diphenhydramine / Ibuprofen — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is this medicine for — can I just take it to help me sleep? ▾
No — this product is specifically for nights when you have both minor pain AND trouble sleeping at the same time. It's not meant to be used as a plain sleep aid. If you're struggling to sleep but don't have any aches or pains, this isn't the right product for you.
How do I take it, and is it okay to take with food? ▾
Take 2 capsules or caplets at bedtime — whichever form your product comes in. Don't take more than that in 24 hours. If it bothers your stomach, go ahead and take it with food or a glass of milk. Most importantly, only take it on nights when you can get a full night's sleep — don't take it if you need to be up and driving in a few hours.
Will this definitely make me drowsy? ▾
Yes, drowsiness is expected and is actually part of how this medicine works — it's not a side effect you can avoid. Because of that, you should not drive, operate heavy machinery, or do anything that requires full alertness after taking it. Alcohol will make the drowsiness much worse, so avoid alcohol while you're using this product.
Are there any serious risks I should know about? ▾
There are two main ones to be aware of. Ibuprofen can increase the risk of stomach bleeding, especially if you're 60 or older, take blood thinners, or drink alcohol regularly. It also raises the risk of heart attack and stroke if used in higher amounts or for longer than directed. Stop taking it and get medical help right away if you notice black or bloody stools, vomit blood, have chest pain, or feel weakness or slurred speech coming on.
Can I take this if I'm pregnant? ▾
It's really important to ask your doctor or pharmacist before using this during pregnancy. Ibuprofen specifically should not be used at 20 weeks of pregnancy or later — unless your doctor has told you it's okay — because it can cause problems for your baby or complications during delivery. If you're breastfeeding, also check with a healthcare professional first.
How long can I use this product? ▾
This is a short-term product. Stop and talk to your doctor if your pain doesn't improve within 10 days, or if sleep problems continue for more than 2 weeks. Ongoing insomnia can sometimes be a sign of a more serious underlying medical condition that needs attention.
Is Diphenhydramine / Ibuprofen available over the counter? ▾
Yes — Diphenhydramine / Ibuprofen is available over the counter (without a prescription) in at least some forms, according to its FDA labeling. Follow the package directions and ask your pharmacist if you're unsure which product is right for you.
When was Diphenhydramine / Ibuprofen first available? ▾
Diphenhydramine / Ibuprofen has been available in the United States since at least 2005, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Diphenhydramine / Ibuprofen? ▾
Diphenhydramine / Ibuprofen is supplied by 58 manufacturers listed in the FDA NDC Directory, including Lil' Drug Store Products, Inc., CVS Pharmacy, Target Corporation.

💬 Answers drafted from Diphenhydramine / Ibuprofen’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerDiphenhydramine / Ibuprofen vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Diphenhydramine / Ibuprofen NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Diphenhydramine / Ibuprofen comes

Diphenhydramine / Ibuprofen is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Advil PM Basic Care Ibuprofen Pm Care One Ibuprofen PM dg health Ibuprofen pm Equaline Ibuprofen Pm Equate Ibuprofen Pm Exchange Select Ibuprofen PM Good Neighbor Pharmacy Ibuprofen Pm Good Sense Ibuprofen Pm Ibuprofen PM Leader Ibuprofen PM Motrin Signature Care Ibuprofen PM Topcare Ibuprofen PM Up And Up Ibuprofen Pm
How this form is used
What it may be used for
  • For relief of occasional sleeplessness when associated with minor aches and pains
  • Helps you fall asleep and stay asleep
Important instructions
  • Advil PM tablets: adults and children 12 and over take 2 caplets at bedtime; do not take more than 2 caplets in 24 hours
  • Amazon Basic Care Ibuprofen PM tablets: adults and children 12 and over take 2 caplets at bedtime; do not take more than 2 caplets in 24 hours
  • Basic Care Ibuprofen PM and Care One Ibuprofen PM tablets: adults and children 12 and over take 2 caplets at bedtime; do not take more than 2 caplets in 24 hours
  • Only take when you have time for a full night's sleep; take with food or milk if stomach upset occurs
Available strengths 2 strengths
38 mg / 200 mg 200 mg / 38 mg
93 FDA-listed product records ⓘ

Capsule

By mouth
Brands Advil Pm Ibuprofen PM Pain Relief Pm
How this form is used
What it may be used for
  • For relief of occasional sleeplessness when associated with minor aches and pains
  • Helps you fall asleep and stay asleep
Important instructions
  • Advil PM capsules: adults and children 12 and over take 2 capsules at bedtime; do not take more than 2 capsules in 24 hours
  • Diphenhydramine HCl and Ibuprofen capsules: adults and children 12 and over take 2 capsules at bedtime; do not take more than 2 capsules in 24 hours
  • Ibuprofen PM and Pain Relief PM capsules: adults and children 12 and over take 2 capsules at bedtime; do not take more than 2 capsules in 24 hours
  • Only take when you have time for a full night's sleep; take with food or milk if stomach upset occurs
Available strengths 2 strengths
25 mg / 200 mg 200 mg / 25 mg
60 FDA-listed product records ⓘ

📊 Diphenhydramine / Ibuprofen across the U.S. market

How Diphenhydramine / Ibuprofen appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms ⓘ
58
Manufacturers
33
Brand names
153
FDA-listed product records ⓘ
2005
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Lil' Drug Store Products, Inc.6%
CVS Pharmacy5%
Target Corporation5%
L. Perrigo Company4%
Haleon US Holdings LLC4%
Kroger Company4%
Other makers70%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Diphenhydramine / Ibuprofen is used

A general measure of how commonly Diphenhydramine / Ibuprofen is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Diphenhydramine / Ibuprofen is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

36
Medicaid prescriptions filled (Q1–Q4 2025)
$375 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Diphenhydramine / Ibuprofen prescribed? Of the 1,596 medications we measure, Diphenhydramine / Ibuprofen ranks #1,554 by Medicaid prescriptions — more than 3% of them.

Where Diphenhydramine / Ibuprofen ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,554 of 1,596
#1,549 Luliconazole Topical 41 Rx #1,550 Plerixafor Injection 40 Rx #1,551 Sunitinib 39 Rx #1,552 Larotrectinib 38 Rx #1,553 Vitamin A 38 Rx #1,554 Diphenhydramine / Ibup... 36 Rx #1,555 Amoxapine 35 Rx #1,556 Mecasermin Injection 35 Rx #1,557 Hepatitis B Vaccine 33 Rx #1,558 Retifanlimab-dlwr Inje... 33 Rx #1,559 Chloramphenicol Inject... 32 Rx

Utilization by Diphenhydramine / Ibuprofen product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet

36 Medicaid prescriptions (Q1–Q4 2025) 100% of Diphenhydramine / Ibuprofen prescriptions shown $375 gross reimbursement (before rebates) ≈ $10 per prescription (gross)

Summed across the 1 of 174 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 895664

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Diphenhydramine / Ibuprofen, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 174 listed Diphenhydramine / Ibuprofen NDCs with Medicaid activity.

🔍 Compare Diphenhydramine / Ibuprofen products

A representative set of FDA-listed product records for Diphenhydramine / Ibuprofen — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 153 of 153 products — FDA National Drug Code Directory. See every product, package size and price: browse all 153 Diphenhydramine / Ibuprofen NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Diphenhydramine / Ibuprofen RxCUI 644895 2 dose forms · 2 strengths

Look up RxCUI 644895 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Ibuprofen PM Advil PM Exchange Select Ibuprofen PM Leader Ibuprofen PM pain relief pm good sense ibuprofen pm Signature Care Ibuprofen PM Care One Ibuprofen PM equaline ibuprofen pm Topcare Ibuprofen PM dg health Ibuprofen pm basic care ibuprofen pm up and up ibuprofen pm good neighbor pharmacy ibuprofen pm Motrin equate ibuprofen pm

🏭 Manufacturers & labelers

Lil' Drug Store Products, Inc. 8 CVS Pharmacy 7 Target Corporation 7 L. Perrigo Company 6 Haleon US Holdings LLC 6 Kroger Company 6 Walgreen Company 5 TOP CARE (Topco Associates LLC) 5 Safeway 4 Aurohealth LLC 4 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 4 Walgreens 4 Rite Aid Corporation 4 Bionpharma Inc. 4 American Sales Company 4 Cardinal Health 110, LLC. dba Leader 3 Aurobindo Pharma Limited 3 Catalent Pharma Solutions, LLC 3 Strategic Sourcing Services LLC 3 Meijer Distribution Inc 3 Army & Air Force Exchange Service 3 Amazon.com Services LLC 3 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 3 Topco Associates LLC 3

…and 16 more on the FDA NDC directory.

RxNorm drug class

Diphenhydramine / Ibuprofen belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 27, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Diphenhydramine / Ibuprofen.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Diphenhydramine / Ibuprofen after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
59
NDC products indexed
153
Distinct labelers/manufacturers represented
58
Linked representative label ⓘ
Lil' Drug Store Products, Inc.
Linked label effective
Nov 27, 2024
Composite sections available
7
Linked SPL Set ID
b876bb40-a38b-445a-bc8a-466b3bfe166d
Linked SPL Document ID
27e68e85-e284-30b9-e063-6394a90aba9b
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 59 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Lil' Drug Store Products, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.