FDA-filed SPL labeling · retrieved through openFDA

Acetaminophen / Aspirin / Caffeine

Acetaminophen, aspirin, and caffeine is an over-the-counter combination used to relieve headache, migraine, minor pain, and other common aches across a range of products.

Brand names Headache ReliefHeadache Relief Extra Strengthmigraine reliefExtra Strength Headache ReliefExcedrin +11 more
Drug classes Nonsteroidal Anti-inflammatory Drug
OTC Forms 4 Routes Oral · Topical
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 174 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 effectiveDec 13, 2024
Clinical labels in scope 174
AvailabilityOTC
Earliest approval/marketing year 1992
FDA-listed product records 505
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Acetaminophen / Aspirin / Caffeine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
This combination of acetaminophen, aspirin, and caffeine is effective for headache, migraine, and common minor pain when used as directed. The most important safety rules are to stay within the daily dose limit to protect your liver, to be aware of stomach bleeding risk from aspirin — especially if you're older or take blood thinners — and to avoid using it with other acetaminophen-containing products. When in doubt, your pharmacist can help you find the right product and check for interactions.

📖 Acetaminophen / Aspirin / Caffeine: Patient Information Guide

A plain-language walkthrough of Acetaminophen / Aspirin / Caffeine — 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

Acetaminophen, aspirin, and caffeine together are used across many OTC products to relieve pain, headache, migraine, and other common discomforts. Specific approvals vary by product:

  • Headache (all supported products)
  • Muscular aches (all supported products)
  • Arthritis pain (most products)
  • Common cold symptoms (most products)
  • Toothache (most products)
  • Premenstrual and menstrual cramps (most products)
  • Sinusitis — listed by Extra Strength Headache Relief capsules and some headache relief tablets
  • Backache — listed by Exaprin Plus tablets and Goodys oral powder
  • Migraine — Amazon Basic Care Migraine Relief, Acetaminophen Aspirin And Caffeine, Excedrin Migraine, Equaline migraine formula, and other migraine-labeled tablets
  • Temporary fever reduction — Exaprin Plus tablets and Extra Strength Pain Reliever capsules
  • Menstrual bloating — Dolex Forte tablets
💊How it's taken

All products in this combination are taken by mouth. Dosing frequency and daily limits differ by product — always follow the directions on your specific label.

  • Migraine-labeled tablets (such as Excedrin Migraine, Amazon Basic Care Migraine Relief, Equaline migraine formula): generally taken as a single dose of 2 tablets with a full glass of water; do not take more than 2 tablets in 24 hours unless directed by a doctor
  • Extra-strength headache products (such as Excedrin Extra Strength Headache and headache-labeled tablets): typically 2 caplets or tablets every 6 hours with a full glass of water; no more than 8 in 24 hours
  • Exaprin Plus and similar products: follow the specific label directions for frequency and daily limit
  • If you miss a dose, take it when you remember, but never double up to make up for a missed one — and never exceed your product's daily maximum
🤒Side effects — in detail

The caffeine in this combination is the source of many common side effects, while aspirin contributes stomach-related ones:

  • Nervousness or irritability
  • Trouble sleeping
  • Rapid heartbeat
  • Stomach upset or pain
  • Nausea
  • Ringing in the ears (tinnitus)

Stop use and get medical help right away if you develop skin redness, blistering, or a rash — this can be a rare but serious skin reaction to acetaminophen. Also seek care immediately if you notice signs of stomach bleeding, such as feeling faint, vomiting blood, or having black or bloody stools.

⚠️Warnings & precautions
  • Liver damage risk: Acetaminophen can cause serious liver damage if you exceed the daily maximum, combine this product with other acetaminophen-containing medicines, or drink 3 or more alcoholic drinks per day while using it.
  • Stomach bleeding: Aspirin is an NSAID and can cause severe stomach bleeding. Risk is higher if you're 60 or older, have had ulcers, take blood thinners or steroids, use other NSAIDs, or drink heavily.
  • Reye's syndrome: Children and teenagers with or recovering from chicken pox or flu-like illness must NOT use aspirin-containing products. Reye's syndrome is a rare but serious condition.
  • Severe allergic reactions: Acetaminophen can rarely cause serious skin reactions. Aspirin can trigger hives, facial swelling, wheezing (asthma), or shock in people with aspirin sensitivity. Stop use and seek emergency help if either occurs.
  • Caffeine overload: This product contains roughly as much caffeine as a cup of coffee. Combining it with other caffeine sources can cause nervousness, irritability, sleeplessness, or a rapid heartbeat.
  • Pregnancy: Avoid aspirin — especially in the last three months of pregnancy — unless your doctor specifically tells you to use it.
🔀What it interacts with

This combination can interact with several common drugs, foods, and substances — always check before combining it with anything else:

  • Warfarin (blood thinner) — both aspirin and acetaminophen can increase bleeding risk; ask your doctor or pharmacist before use
  • Other acetaminophen-containing products — doubling up raises serious liver damage risk; read every label
  • NSAIDs (ibuprofen, naproxen, other aspirin products) — combining increases stomach bleeding risk
  • Steroid drugs — raise stomach bleeding risk when used with aspirin
  • Prescription drugs for diabetes, gout, or arthritis — aspirin may interfere with these; ask your pharmacist
  • Diuretics (water pills) — ask a doctor before combining with this product
  • Alcohol — 3 or more drinks a day significantly raises risk of liver damage and stomach bleeding
  • Caffeine from food, drinks, or other medicines — too much total caffeine can cause nervousness, trouble sleeping, or rapid heartbeat

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
  • Tell your doctor if you have liver disease — acetaminophen can be harmful
  • Ask a doctor if you have stomach ulcers, a history of stomach bleeding, or frequent heartburn
  • Ask a doctor if you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • Ask a doctor if you have asthma — aspirin can trigger breathing problems in some people
  • Children and teenagers with chicken pox or flu-like illness must not use this product (aspirin and Reye's syndrome risk)
  • Children under 12 should not use most formulations without a doctor's guidance
  • Adults 60 and older are at higher risk for stomach bleeding from aspirin
  • Pregnant or breastfeeding? Ask a health professional before use; avoid aspirin in the last three months of pregnancy unless a doctor directs it
  • If you are not sure whether another drug you take contains acetaminophen, ask your pharmacist before taking this product
🚑If you take too much

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for both adults and children — even if no symptoms are present yet, because acetaminophen overdose can cause severe liver damage that may not be immediately obvious.

📦How to store it

store at controlled room temperature 20°-25°C (68°-77°F) • close cap tightly after use • read all product information before using.

📄 Written from Acetaminophen / Aspirin / Caffeine’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 Acetaminophen / Aspirin / Caffeine — the kind of thing our pharmacy team would talk through with you at the counter.

What's the difference between the migraine version and the regular headache version?
The migraine-labeled products — like Excedrin Migraine and Amazon Basic Care Migraine Relief — are specifically approved to treat migraine and are generally taken as one dose (2 tablets) with no more than 2 tablets in a 24-hour period. The extra-strength headache products are approved for a broader list of minor pains and can typically be taken every 6 hours as needed, up to a higher daily maximum. The ingredients are the same combination, but the approved use and dosing schedule differ — so always use the product that matches what you're treating and follow its label.
Can I take this with other pain relievers or cold medicines?
Be careful — many OTC cold, sinus, and pain products already contain acetaminophen. Stacking them with this product can quickly push you over the safe daily limit and raise your risk of serious liver damage. Always read every label before combining products, and when in doubt, ask your pharmacist to help you check.
Is it safe to have a drink or two while taking this?
It's best to avoid alcohol while using this product. Drinking 3 or more alcoholic beverages daily while taking acetaminophen significantly raises the risk of liver damage. Aspirin also increases the chance of stomach bleeding when combined with alcohol. An occasional drink may be lower risk, but if you drink regularly, talk to your doctor before using this combination.
Can my child take this?
Most products in this combination are not recommended for children under 12 without a doctor's guidance. More importantly, children or teenagers who have — or are recovering from — chicken pox or a flu-like illness must not take any product containing aspirin. This is because of a rare but serious condition called Reye's syndrome. If your child needs pain or fever relief, ask your pediatrician or pharmacist for a safer alternative.
I'm pregnant — is this safe to take?
You should check with your doctor before using this product during pregnancy. The label specifically warns against using aspirin in the last three months of pregnancy because it can cause problems for the baby or complications during delivery. Even earlier in pregnancy, it's best to get professional guidance before taking any pain reliever.
How will I know if I'm having a serious reaction I need to worry about?
Stop taking the product and get medical help right away if you develop a skin rash, blisters, or reddening — that can be a rare but serious reaction to acetaminophen. Also seek care immediately if you feel faint, vomit blood, notice black or bloody stools, or have stomach pain that won't go away — those are warning signs of stomach bleeding from aspirin. For migraine users: if your migraine isn't relieved or gets worse after the first dose, or if new unexpected symptoms appear, call your doctor.
Is Acetaminophen / Aspirin / Caffeine available over the counter?
Yes — Acetaminophen / Aspirin / Caffeine 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 Acetaminophen / Aspirin / Caffeine first available?
Acetaminophen / Aspirin / Caffeine has been available in the United States since at least 1992, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Acetaminophen / Aspirin / Caffeine?
Acetaminophen / Aspirin / Caffeine is supplied by 133 manufacturers listed in the FDA NDC Directory, including Lil' Drug Store Products, Inc., Walgreens, Medtech Products Inc..

💬 Answers drafted from Acetaminophen / Aspirin / Caffeine’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

💊 How Acetaminophen / Aspirin / Caffeine comes

Acetaminophen / Aspirin / Caffeine is available in 4 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 Excedrin Excedrin Extra Strength Excedrin Extra Strength Pain Reliever Excedrin Migraine Extra Strenght Headache Relief Extra Strength Headache Relief Extra Strength Pain Reliever GenCare Headache Relief Good Sense Migraine Formula Headache Relief Migraine Formula Migraine Relief
How this form is used
What it may be used for
  • Amazon Basic Care Migraine Relief and Acetaminophen Aspirin And Caffeine are indicated to treat migraine
  • Equaline migraine formula tablets are indicated to treat migraine
  • Exaprin Plus temporarily relieves minor aches and pains from headache, muscular aches, minor arthritis pain, backache, common cold, menstrual cramps, and toothache, and temporarily reduces fever
  • Dolex Forte temporarily relieves minor aches and pains from headache, a cold, arthritis, muscular aches, toothache, premenstrual and menstrual cramps, and bloating
Important instructions
  • Amazon Basic Care Migraine Relief and Acetaminophen Aspirin And Caffeine: take 2 tablets with a full glass of water; do not take more than 2 tablets in 24 hours unless directed by a doctor
  • Equaline migraine formula: take 2 tablets with a full glass of water; do not take more than 2 tablets in 24 hours unless directed by a doctor
  • Adults under 18 years: ask a doctor before using migraine-labeled tablets
  • Follow the specific dosing directions on your product label; do not exceed the stated daily maximum
Available strengths 7 strengths
Show 1 more strength Show fewer strengths
481 FDA-listed product records

Oral powder

By mouth
Brands Goodys Extra Strength
How this form is used
What it may be used for
  • Goodys temporarily relieves minor aches and pains from headache, minor arthritis pain, muscular aches, a cold, backache, toothache, and menstrual cramps
Important instructions
  • Take the powder by mouth as directed on the Goodys label
  • Do not exceed the daily maximum listed on your package
  • Follow your specific product directions carefully
Available strengths 5 strengths
14 FDA-listed product records

Capsule

By mouth
Brands Extra Strength Headache Relief Extra Strength Pain Reliever
How this form is used
What it may be used for
  • Pain Terminator temporarily relieves minor aches and pains from headache, muscular aches, arthritis pain, a cold, toothache, and premenstrual and menstrual cramps
  • Extra Strength Pain Reliever temporarily relieves fever and minor aches and pains from headache, colds, muscular aches, menstrual discomfort, toothaches, and minor arthritis pain
  • Extra Strength Headache Relief temporarily relieves minor aches and pains from headache, a cold, arthritis, muscular aches, sinusitis, toothache, and premenstrual and menstrual cramps
Important instructions
  • Take capsules by mouth with a full glass of water
  • Do not exceed the daily maximum listed on your specific product label
  • Children under 12: ask a doctor before use
Available strengths 2 strengths
6 FDA-listed product records

Topical cream, ointment or gel

By mouth · On the skin
Brands Excedrin Extra Strength Headache Headache Relief
How this form is used
What it may be used for
  • Excedrin Extra Strength Headache temporarily relieves minor aches and pains from headache, a cold, arthritis, muscular aches, toothache, and premenstrual and menstrual cramps
  • Headache Relief temporarily relieves minor aches and pains from headache, a cold, arthritis, muscular aches, sinusitis, toothache, and premenstrual and menstrual cramps
Important instructions
  • Excedrin Extra Strength Headache: drink a full glass of water with each dose; adults and children 12 and over may take 2 caplets every 6 hours, not more than 8 caplets in 24 hours
  • Children under 12: ask a doctor before use
  • Do not exceed the maximum daily amount listed on your product label
Available strengths 1 strength
2 FDA-listed product records

📊 Acetaminophen / Aspirin / Caffeine across the U.S. market

How Acetaminophen / Aspirin / Caffeine 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.

4
Dose forms
133
Manufacturers
40
Brand names
505
FDA-listed product records
1992
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.

Also listed with the FDA, not a patient dose form: Kit (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Lil' Drug Store Products, Inc.9%
Walgreens7%
Medtech Products Inc.4%
CVS Pharmacy4%
Haleon US Holdings LLC4%
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC3%
Other makers69%

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

📈 How widely Acetaminophen / Aspirin / Caffeine is used

A general measure of how commonly Acetaminophen / Aspirin / Caffeine 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 Acetaminophen / Aspirin / Caffeine 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.

11,352
Medicaid prescriptions filled (Q1–Q4 2025)
$88,636 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Acetaminophen / Aspirin / Caffeine prescribed? Of the 1,596 medications we measure, Acetaminophen / Aspirin / Caffeine ranks #906 by Medicaid prescriptions — more than 43% of them.

Where Acetaminophen / Aspirin / Caffeine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Acetaminophen / Aspirin / Caffeine 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.

acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet

11,352 Medicaid prescriptions (Q1–Q4 2025) 100% of Acetaminophen / Aspirin / Caffeine prescriptions shown $88,636 gross reimbursement (before rebates) ≈ $7.81 per prescription (gross)

Summed across the 13 of 574 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308297

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 Acetaminophen / Aspirin / Caffeine, 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 13 of 574 listed Acetaminophen / Aspirin / Caffeine NDCs with Medicaid activity.

🔍 Compare Acetaminophen / Aspirin / Caffeine products

A representative set of FDA-listed product records for Acetaminophen / Aspirin / Caffeine — 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 200 of 505 products — FDA National Drug Code Directory. See every product, package size and price: browse all 505 Acetaminophen / Aspirin / Caffeine 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) Acetaminophen / Aspirin / Caffeine RxCUI 466584 3 dose forms · 8 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 375995 In current FDA listings
    Clinical drug / strength (SCD) acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG RxCUI 827318

Look up RxCUI 466584 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

Headache Relief Headache Relief Extra Strength migraine relief Extra Strength Headache Relief Excedrin Extra Strenght Headache Relief Excedrin Migraine Excedrin Extra Strength Pain Reliever migraine formula Extra Strength Pain Reliever good sense migraine formula Goodys Extra Strength GenCare Headache Relief Excedrin Extra Strength Excedrin Extra Strength Headache Topcare Migraine Relief

🏭 Manufacturers & labelers

Lil' Drug Store Products, Inc. 29 Walgreens 22 Medtech Products Inc. 14 CVS Pharmacy 14 Haleon US Holdings LLC 12 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 11 Rite Aid Corporation 11 The Kroger Co. 11 Opmx Llc 10 Walgreen Company 9 Cardinal Health 110, LLC. DBA Leader 9 Topco Associates LLC 9 L. Perrigo Company 8 Lil Drug Store Products, Inc 8 Spirit Pharmaceutical LLC 8 Strategic Sourcing Services LLC 8 L.N.K. International, Inc. 7 Target Corporation 7 Publix Super Markets Inc 7 P & L Development, LLC 6 Pioneer Life Sciences, LLC 6 Amazon.com Services LLC 6 Family Dollar (FAMILY WELLNESS) 6 Navajo Manufacturing Company Inc. 6

…and 16 more on the FDA NDC directory.

RxNorm drug class

Acetaminophen / Aspirin / Caffeine belongs to the Platelet Aggregation Inhibitor class.

Pharmacologic class Platelet Aggregation Inhibitor, Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other agents for local oral treatment, Platelet aggregation inhibitors excl. heparin, Salicylic acid and derivatives
How it works Cyclooxygenase Inhibitors

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 Dec 13, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Acetaminophen / Aspirin / Caffeine.
📈
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 Acetaminophen / Aspirin / Caffeine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
174
NDC products indexed
505
Distinct labelers/manufacturers represented
133
Linked representative label
Lil' Drug Store Products, Inc.
Linked label effective
Dec 13, 2024
Composite sections available
8
Linked SPL Set ID
40aeb2c5-a37b-446d-9918-8378a75ff327
Linked SPL Document ID
292c702d-fbca-eda6-e063-6394a90ac866
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 174 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.