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Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine 250 mg; 250 mg; 65 mg Tablet, Coated, 80-count — NDC 59726-0586-80 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine 250 mg; 250 mg; 65 mg Tablet, Coated, 80-count — NDC 59726-586-80 (Billing 59726-0586-80)

by P & L Development, LLC · 1 BOTTLE, PLASTIC in 1 BOTTLE / 80 TABLET, COATED in 1 BOTTLE, PLASTIC

This is a package of 80 tablets of Headache Relief Extra Strength Acetaminophen, Aspirin, Caffeine 250 mg; 250 mg; 65 mg Tablet, Coated from P & L Development, LLC, marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 59726-0586-80
🏷️ FDA NDC (as labeled) 59726-586-80 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 59726-586-80 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
59726 labeler · 586 product · 80 package
Package marketed since
Jun 20, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5972658680 1
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59726-586-80
Product NDC 59726-586
11-digit billing NDC 59726058680
RxCUI 308297
UNII 362O9ITL9D, R16CO5Y76E, 3G6A5W338E
Application # M013
SPL Set ID 55e996cd-ef22-4e09-a05c-8aa994e4540b
Established class (EPC) Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor; Central Nervous System Stimulant; Methylxanthine
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production; Decreased Platelet Aggregation; Central Nervous System Stimulation
Chemical class Anti-Inflammatory Agents, Non-Steroidal; Xanthines
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-20
Route ORAL
Dosage form TABLET, COATED
Substance ACETAMINOPHEN; ASPIRIN; CAFFEINE
Quick answers
  • RxCUI (RxNorm): 308297
Why two NDCs? The FDA registers this code as 59726-586-80 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59726-0586-80. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine 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
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

This is an over-the-counter oral gel containing three active ingredients commonly combined in headache products. Acetaminophen and aspirin are pain relievers and anti-inflammatory agents typically used to reduce pain and swelling. Caffeine is a central nervous system stimulant that is often included in pain-relief formulas to enhance their effects. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for this category rather than undergoing individual application review.

5
Nutrient depletion considerations

Acetaminophen, Aspirin, Caffeine may be associated with lower levels of 5 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen, Aspirin, Caffeine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
59726-0586-80 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 BOTTLE / 80 TABLET, COATED in 1 BOTTLE, PLASTIC 2026-06-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
leader migraine relief 250 mg/1; 250 mg/1; 65 mg 70000-0611-01 Cardinal 80 tablets $0.065 — Availability likely —
Leader Migraine Relief 250 mg/1; 250 mg/1; 65 mg 70000-0247-01 Cardinal 24 tablets $0.065 — Availability likely —
good sense migraine formula 250 mg/1; 250 mg/1; 65 mg 00113-0374-62 L. 24 tablets $0.065 — Availability likely —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 46122-0690-78 Amerisource 100 tablets $0.065 — Availability likely —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 70000-0146-01 Cardinal 24 tablets $0.065 — Availability likely —
foster and thrive migraine relief 250 mg/1; 250 mg/1; 65 mg 70677-1133-01 Strategic 50 tablets $0.065 — Availability likely —
good neighbor pharmacy migraine relief 250 mg/1; 250 mg/1; 65 mg 24385-0365-71 Amerisource 50 tablets $0.065 — Availability likely —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 83324-0063-24 Chain 24 tablets $0.067 — Discontinued —
topcare migraine relief 250 mg/1; 250 mg/1; 65 mg 36800-0934-60 Topco 20 tablets — — FDA listed —
dg health migraine relief 250 mg/1; 250 mg/1; 65 mg 55910-0448-27 Dolgencorp 80 tablets — — FDA listed —
basic care migraine relief 250 mg/1; 250 mg/1; 65 mg 72288-0295-27 Amazon.com 80 tablets — — FDA listed —
Extraprin 250 mg/1; 250 mg/1; 65 mg 54257-0858-02 Magno-Humphries, 100 tablets — — FDA listed —
DG Health migraine relief 250 mg/1; 250 mg/1; 65 mg 55910-0374-62 Dolgencorp, 24 tablets — — FDA listed —
basic care migraine relief 250 mg/1; 250 mg/1; 65 mg 72288-0374-82 Amazon.com 200 tablets — — FDA listed —
TopCare EXTRA STRENGTH Headache Relief 250 mg/1; 250 mg/1; 65 mg 76162-0142-01 Topco 100 tablets — — FDA listed —
good sense migraine formula 250 mg/1; 250 mg/1; 65 mg 82804-0002-30 Proficient 30 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 41163-0334-08 United 24 tablets — — FDA listed —
Headache Formula Extra Strength 250 mg/1; 250 mg/1; 65 mg 55301-0334-12 ARMY 100 tablets — — FDA listed —
Extra Strength Headache Relief 250 mg/1; 250 mg/1; 65 mg 00363-7214-25 WALGREENS 250 tablets — — FDA listed —
Extra Strength Headache Relief 250 mg/1; 250 mg/1; 65 mg 00363-8992-10 WALGREENS 100 tablets — — FDA listed —
Migraine Formula 250 mg/1; 250 mg/1; 65 mg 79481-0211-00 Meijer, 80 tablets — — FDA listed —
ValuMeds Extra Strength Headache Relief 250 mg/1; 250 mg/1; 65 mg 82725-1023-01 Cabinet 300 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 83324-0331-01 Chain 100 tablets — — FDA listed —
good sense headache relief 250 mg/1; 250 mg/1; 65 mg 00113-1855-27 L. 80 tablets — — FDA listed —
migraine relief 250 mg/1; 250 mg/1; 65 mg 30142-0896-62 Kroger 24 tablets — — FDA listed —
migraine formula 250 mg/1; 250 mg/1; 65 mg 41250-0374-71 Meijer 50 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 55319-0511-10 Family 100 tablets — — FDA listed —
Migraine Relief 250 mg/1; 250 mg/1; 65 mg 55319-0970-10 Family 100 tablets — — FDA listed —
EXTRA STRENGTH Headache Relief geltabs 250 mg/1; 250 mg/1; 65 mg 70692-0132-20 Strive 200 tablets — — FDA listed —
good sense migraine formula 250 mg/1; 250 mg/1; 65 mg 85766-0180-01 Sportpharm 100 tablets — — FDA listed —
Up and Up Migraine Relief 250 mg/1; 250 mg/1; 65 mg 11673-0374-78 Target 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 11673-0686-20 TARGET 20 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 21130-0586-20 Safeway, 20 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 30142-0625-10 The 100 tablets — — FDA listed —
Equaline migraine formula 250 mg/1; 250 mg/1; 65 mg 41163-0374-71 United 50 tablets — — FDA listed —
migraine formula 250 mg/1; 250 mg/1; 65 mg 42507-0374-62 HyVee 24 tablets — — FDA listed —
good sense migraine formula 250 mg/1; 250 mg/1; 65 mg 00113-1619-27 L. 80 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 30142-0586-20 The 20 tablets — — FDA listed —
Care One migraine relief 250 mg/1; 250 mg/1; 65 mg 41520-0374-62 American 24 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 49035-0786-80 EQUATE 80 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 50844-0258-08 L.N.K. 24 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 59726-0011-50 P 50 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 30142-0865-24 The 24 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 37808-0586-20 H 20 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 00363-0865-25 Walgreens 250 tablets — — FDA listed —
basic care headache relief 250 mg/1; 250 mg/1; 65 mg 72288-0252-27 Amazon.com 80 tablets — — FDA listed —
migraine relief 250 mg/1; 250 mg/1; 65 mg 11822-0374-01 Rite 100 tablets — — FDA listed —
Signature Care Migraine Relief 250 mg/1; 250 mg/1; 65 mg 21130-0569-62 Safeway 24 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 55910-0345-08 DOLGENCORP, 24 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 00363-0586-20 Walgreens 20 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 55910-0686-20 Dolgencorp, 20 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 56062-0934-12 Publix 100 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 00363-1150-25 Walgreens 250 tablets — — FDA listed —
Sedalmex Forte 250 mg/1; 250 mg/1; 65 mg 27854-0303-01 Belmora 40 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 67091-0112-10 WinCo 100 tablets — — FDA listed —
migraine relief 250 mg/1; 250 mg/1; 65 mg 00363-0374-62 Walgreen 24 tablets — — Discontinued —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 69842-0586-02 CVS 200 tablets — — FDA listed —
Headache Relief 250 mg/1; 250 mg/1; 65 mg 70692-0142-31 Strive 300 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mg 41250-0334-08 Meijer 24 tablets — — Discontinued —
dg health headache relief 250 mg/1; 250 mg/1; 65 mg 55910-0639-27 Dolgencorp 80 tablets — — FDA listed —
migraine relief 250 mg/1; 250 mg/1; 65 mg 59779-0374-62 CVS 24 tablets — — FDA listed —
GenCare Headache Relief 250 mg/1; 250 mg/1; 65 mg 72090-0033-01 Pioneer 300 tablets — — Discontinued —
Topcare Migraine Relief 250 mg/1; 250 mg/1; 65 mg 36800-0533-62 Topco 24 tablets — — FDA listed —
migraine formula 250 mg/1; 250 mg/1; 65 mg 37808-0374-78 H 100 tablets — — FDA listed —
Dolex Forte 250 mg/1; 250 mg/1; 65 mg 55758-0509-24 Pharmadel 24 tablets — — FDA listed —
migraine relief 250 mg/1; 250 mg/1; 65 mg 00363-1235-60 Walgreen 20 tablets — — FDA listed —
Headache Relief Extra Strength 250 mg/1; 250 mg/1; 65 mgthis 59726-0586-80 P 80 tablets — — FDA listed —
HyVee Extra Strength Headache Relief CAPLET 250 mg/1; 250 mg/1; 65 mg 42507-0142-01 HyVee 100 tablets — — FDA listed —
migraine relief 250 mg/1; 250 mg/1; 65 mg 72288-0286-27 Amazon.com 80 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeRound
ImprintP
Size13 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 2165RE0K14
    A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII D65DG142WK
    Maltitol is a sugar alcohol made by hydrogenating maltose. It's used as a sweetener and filler in medicines to improve taste and add bulk to tablets and capsules.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

18 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesblack printing ink, corn starch, D&C yellow #10 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hydroxypropyl cellulose, hydroxypropyl cellulose-low substituted, hypromellose, iron oxide black, maltitol, povidone, purified water, stearic acid, talc, titanium dioxide

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerP & L Development, LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code59726
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio124 products on file

More NDCs from P & L Development, LLC labeler code 59726

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps

⏱️ Dosage and Administration 51 words ▾

Directions do not use more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 geltabs every 6 hours; do not take more than 8 geltabs in 24 hours children under 12 years: do not use unless directed by a doctor

⚠️ Warnings ~3 min read ▾

Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness 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. Allergy alert : Aspirin may cause severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing) 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 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 Caffeine warning : The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug or are under a doctor’s care for any serious condition Stop use and ask doctor if an allergic reaction occurs.

Seek medical help right away. 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 ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts more than 3 days any new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin 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 (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.

📦 Storage and Handling 6 words ▾

Other information store between 20º-25ºC (68º-77ºF)

🧪 Active Ingredient 18 words ▾

Active ingredients (in each geltab) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 44 words ▾

Inactive ingredients black printing ink, corn starch, D&C yellow #10 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hydroxypropyl cellulose, hydroxypropyl cellulose-low substituted, hypromellose, iron oxide black, maltitol, povidone, purified water, stearic acid, talc, titanium dioxide

🎯 Purpose 8 words ▾

Purposes Pain reliever Pain reliever Pain reliever aid

📄 Do Not Use 44 words ▾

Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

📄 Ask a Doctor Before Use If 45 words ▾

Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic

📄 Ask a Doctor or Pharmacist Before Use If 33 words ▾

Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis taking any other drug or are under a doctor’s care for any serious condition

📄 Stop Use and Ask a Doctor If 88 words ▾

Stop use and ask doctor if an allergic reaction occurs. Seek medical help right away. 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 ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts more than 3 days any new symptoms occur These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 47 words ▾

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin 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 44 words ▾

Keep out of reach of children. 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.

📄 Questions or Comments 8 words ▾

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel 100 words ▾

Principal Display Panel COMPARE TO Excedrin® Extra Strength active ingredients† Extra Strength Headache Relief ACETAMINOPHEN 250 mg ASPIRIN (NSAID ) 250 mg CAFFEINE 65 mg Pain Reliever/Pain Reliever Aid GELTABS †This product is not manufactured or distributed by Haleon Group of Companies, distributor of Excedrin® Extra Strength. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY PL DEVELOPMENTS 200 Hicks Street Westbury, NY 11590

Package Label green Amazon Wellness Basics Extra Strength Relief Geltabs Amazon Wellness Basics Extra Strength Relief Geltabs 80 Ct.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Headache Relief Extra Strength (this brand).

Top reported reactions

Nausea14
Completed Suicide12
Headache12
Pruritus10
Dyspnoea9
Feeling Abnormal8
Hypertension8

Age at onset

Child1
Adult12
Elderly4

Reporter sex

155 reports
Male · 28%
Female · 71%
Unknown · 1%

Serious outcomes

Death29
Life-threatening5
Disabling4
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 16 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by P & L Development, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
P & L Development, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 59726-0503-00 · P 59726-0592-16 · P →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.