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Aspirin 81mg Enteric Coated 81 mg Tablet, Delayed Release — NDC 55154-2607-00 package photo

Aspirin 81mg Enteric Coated 81 mg Tablet, Delayed Release

by Cardinal Health 107, LLC · 10 BLISTER PACK in 1 BAG (55154-2607-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
NDC 55154-2607-00
🏷️ FDA NDC (as labeled) 55154-2607-0 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 20, 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

🆔 Identity & classification

FDA NDC (as labeled) 55154-2607-0
Product NDC 55154-2607
11-digit billing NDC 55154260700
RxCUI 308416
UNII R16CO5Y76E
UPC 0055154260701
Application # M013
SPL Set ID 277723db-3578-4842-92eb-2de325f87649
Established class (EPC) Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production; Decreased Platelet Aggregation
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-28
Route ORAL
Dosage form TABLET, DELAYED RELEASE
Substance ASPIRIN
Why two NDCs? The FDA registers this code as 55154-2607-0 — a 5-4-1 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 package segment → 55154-2607-00. 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.

🏭 Manufacturer & labeler

LabelerCardinal Health 107, LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code55154
First marketedJul 2026
Product typeHuman Otc Drug
Portfolio477 products on file
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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Aspirin is used to temporarily relieve common minor pains — things like headaches, backaches, muscle aches, toothaches, menstrual cramps, and discomfort from a cold — and to reduce...
  • Generally, no — aspirin should not be given to children under 12. More importantly, children and teenagers who have or are recovering from chickenpox or a flu-like illness should n...
  • Yes, stomach upset, heartburn, and nausea are real possibilities with aspirin. Taking it with a full glass of water helps. Some people tolerate enteric-coated or delayed-release fo...
  • Does aspirin upset your stomach? What can I do about it?
📖 Read our full Aspirin guide →
3
Nutrient depletion considerations

Aspirin may be associated with lower levels of 3 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Aspirin 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.

💊 What it looks like

Color yellow
ShapeRound
ImprintA1
Size8 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

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

The official label also statesAcrycoat, Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow# 10, Lactose, Microcrystalline Cellulose, Polysorbate 80, Sodium Hydroxide, Talc, Titanium Dioxide, Triethyl Citrate, Yellow Oxide of Iron.

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aspirin Regimen 81 mg 70000-0603-01 Cardinal 32 tablets $0.014 — Availability likely —
Aspirin 81 mg 70677-1121-01 STRATEGIC 180 tablets $0.014 — Availability likely —
Aspirin Low Dose 81 mg 00904-6751-80 Major 1000 tablets $0.014 — Availability likely —
Aspirin Regimen 81 mg 70000-0604-01 Cardinal 36 tablets $0.014 — Availability likely —
Aspirin Low Dose 81 mg 70677-1260-01 Strategic 120 tablets $0.014 — Availability likely —
Aspirin 81 mg Low dose 83324-0090-36 CHAIN 36 tablets $0.014 — Availability likely —
Adult Low Dose Aspirin 81 mg 57237-0349-10 Rising 1000 tablets $0.014 — Availability likely —
Aspirin 81 mg 46122-0791-66 Amerisource 120 tablets $0.014 — Availability likely —
foster and thrive aspirin 81 mg 70677-1310-01 McKesson 1000 tablets $0.014 — Availability likely —
Aspirin 81 mg Low Dose 83324-0089-05 CHAIN 500 tablets $0.014 — Availability likely —
Aspirin 81 81 mg 46122-0598-48 Amerisource 180 tablets $0.014 — Availability likely —
Aspirin Low Dose 81 mg 00536-1234-41 Rugby 120 tablets $0.014 — Availability likely —
Aspirin Enteric Coated 81 mg 63868-0363-20 CHAIN 120 tablets $0.015 — FDA listed —
Aspirin 81 mg 63868-0373-05 Chain 500 tablets $0.015 — FDA listed —
Aspirin 81 mg 63868-0469-36 Chain 36 tablets $0.015 — FDA listed —
Low Dose Aspirin Enteric Safety Coated 81 mg 49483-0328-01 Time-Cap 100 tablets — — FDA listed —
Low Dose Miniprin Enteric Safety Coated 81 mg 49483-0330-10 Time-Cap 1000 tablets — — FDA listed —
Low Dose Aspirin Enteric Safety Coated 81 mg 49483-0381-10 Time-Cap 1000 tablets — — FDA listed —
Aspirin 81 mg 61504-0080-01 AMERIFOODS 120 tablets — — FDA listed —
Aspirin 81mg Enteric coated Low Strength Aspirin Regimen 81 mg 69168-0006-50 Allegiant 50 tablets — — FDA listed —
Aspirin Low Dose 81 mg 79481-6450-05 Meijer 365 tablets — — FDA listed —
Aspirin Low Dose 81 mg 41163-0945-32 United 120 tablets — — FDA listed —
Aspirin 81 mg 50090-7624-00 A-S 120 tablets — — FDA listed —
Aspirin Low Dose 81 mg 55301-0600-32 ARMY 120 tablets — — FDA listed —
Adult Low Dose Pain Reliever 81 mg 55681-0403-03 TWIN 300 tablets — — FDA listed —
Aspirin 81 mg 57344-0146-08 AAA 120 tablets — — FDA listed —
ASPIRIN Low Strength 81 mg 59779-0945-32 CVS 120 tablets — — Discontinued —
Aspirin Low Dose 81 mg 63941-0600-27 Valu 32 tablets — — FDA listed —
Aspirin 81 mg 68998-0080-01 Marc 120 tablets — — FDA listed —
ASPIRIN Low Dose 81 mg 68998-0146-01 Marc 180 tablets — — FDA listed —
Aspirin Enteric Coated Low Dose 81 mg 00363-6450-14 Walgreen 500 tablets — — FDA listed —
Adult Low Dose Aspirin 81 mg 69517-0001-05 HealthLife 500 tablets — — Discontinued —
Pain Relief Aspirin Low Dose 81 mg 11822-0600-03 Rite 120 tablets — — FDA listed —
Aspirin 81 mg Low Dose 41250-0600-14 Meijer 500 tablets — — FDA listed —
Aspirin 81 mg 43063-0724-35 PD-Rx 35 tablets — — FDA listed —
Aspirin 81 mg Low Dose 51316-0601-06 CVS 200 tablets — — FDA listed —
Low Dose Aspirin 81 mg 53943-0080-01 DISCOUNT 120 tablets — — FDA listed —
adult low dose aspirin 81 mg 63941-0246-03 VALU 100 tablets — — FDA listed —
Aspirin Low Dose 81 mg 68196-0901-96 Sam's 365 tablets — — FDA listed —
aspirin 81 mg 71679-0301-00 Health 135000 tablets — — FDA listed —
Aspirin Low Dose 81 mg 50090-6929-00 A-S 120 tablets — — FDA listed —
Aspirin Low Dose 81 mg 55910-0945-12 DOLGENCORP, 100 tablets — — FDA listed —
Aspirin 81mg 81 mg 72036-0080-01 HARRIS 120 tablets — — FDA listed —
Aspirin 81mg Enteric Coated 81 mg 77333-0031-20 Gendose 1 tablet — — FDA listed —
Adult Low Dose Aspirin 81 mg 00615-8613-05 NCS 15 tablets — — FDA listed —
Aspirin 81 mg 37808-0600-32 H 120 tablets — — FDA listed —
Low Dose Aspirin 81 mg 49035-0563-11 Wal-Mart 60 tablets — — FDA listed —
Aspirin 81 mg 73376-0001-50 INVAHEALTH 500 tablets — — FDA listed —
Aspirin 81mg Enteric Coated 81 mg 83586-0104-05 HHH 1000 tablets — — FDA listed —
Low Dose Aspirin 81 mg 87438-0003-01 Pinnacle 1000 tablets — — FDA listed —
pain relief aspirin Low Dose 81 mg 11822-6451-04 Rite 500 tablets — — FDA listed —
Adult Low Dose Aspirin 81 mg 16103-0356-09 Pharbest 120 tablets — — FDA listed —
Aspirin 81mg Adult Low Dose 81 mg 36800-0880-08 TopCare 100 tablets — — FDA listed —
Aspirin 81mg Adult Low Dose 81 mg 41250-0146-11 Meijer 365 tablets — — Discontinued —
Aspirin 81 mg 42507-0080-04 HYVEE 500 tablets — — FDA listed —
Aspirin 81 mg 57344-0080-01 AAA 120 tablets — — FDA listed —
NobleAid PAIN RELIEVER 81 mg 81533-0600-10 Noble 100 tablets — — FDA listed —
Aspirin 81 mg Low Dose 37808-0246-01 HEB 180 tablets — — FDA listed —
Aspirin 81 MG 41250-0780-01 Meijer 120 tablets — — FDA listed —
Aspirin Low Dose 81 mg 67091-0123-12 WinCo 120 tablets — — FDA listed —
Aspirin Low Dose 81 mg 68016-0642-12 Chain 120 tablets — — Discontinued —
Aspirin 81 mg 83324-0067-12 Chain 120 tablets — — FDA listed —
Adult Low Dose Enteric Coated Aspirin 81 mg 37835-0571-05 Bi-Mart 500 tablets — — FDA listed —
Aspirin Low Dose 81 mg 50090-6928-01 A-S 120 tablets — — FDA listed —
Adult Low Strength Aspirin 81 mg 53943-0146-01 DISCOUNT 180 tablets — — FDA listed —
Aspirin 81 mg 55910-0600-32 DOLGENCORP, 120 tablets — — FDA listed —
Low Dose Aspirin 81 mg 63941-0081-01 VALU 120 tablets — — FDA listed —
Aspirin Low Dose 81 mg 68788-4028-08 Preferred 120 tablets — — FDA listed —
Aspirin Low Dose 81 mg 68788-8334-01 Preferred 100 tablets — — FDA listed —
Aspirin 81 mg 50804-0880-01 GOODSENSE 120 tablets — — FDA listed —
Aspi-Cor 81 mg 50844-0675-03 L.N.K. 10 tablets — — FDA listed —
Low Dose Aspirin 81 mg 51316-0456-51 CVS 365 tablets — — FDA listed —
Aspirin 81 mg 00363-0587-14 Walgreen 500 tablets — — FDA listed —
Low Dose Aspirin 81 mg 68391-0481-93 BJWC 365 tablets — — FDA listed —
Aspirin Low Dose 81 mg 17856-3086-01 ATLANTIC 1 tablet — — FDA listed —
Aspirin 81mg 81 mg 21130-0428-12 BETTER 120 tablets — — FDA listed —
Aspirin 81 mg 36800-0545-60 Topco 180 tablets — — FDA listed —
Low Dose Aspirin 81 mg 41163-0563-06 United 200 tablets — — FDA listed —
Aspirin 81 mg 50090-7623-01 A-S 120 tablets — — FDA listed —
Aspirin Enteric Coated 81 mg 59779-0600-06 CVS 200 tablets — — FDA listed —
Aspirin Low Dose 81 mg 63981-0563-96 COSTCO 365 tablets — — FDA listed —
Aspirin 81mg Enteric Coated 81 mg 80513-0287-03 Advanced 300 tablets — — FDA listed —
Adult Low Dose Aspirin 81 mg 80513-0289-03 Advanced 300 tablets — — FDA listed —
Low Dose Aspirin 81 mg 87509-0981-05 Famora 500 tablets — — FDA listed —
Aspirin Low Dose 81 mg 50844-0600-32 L.N.K. 120 tablets — — FDA listed —
Low Dose Aspirin 81 mg 55319-0601-32 Family 120 tablets — — FDA listed —
Aspirin Low Dose 81 mg 55910-0563-17 DOLGENCORP, 300 tablets — — FDA listed —
Aspirin 81 MG 63941-0080-04 VALU 500 tablets — — FDA listed —
Aspirin enteric coated low dose 81 mg 00363-0563-06 Walgreen 200 tablets — — FDA listed —
Aspirin 81 mg 68788-8598-08 Preferred 120 tablets — — FDA listed —
Aspirin 81 mg 71141-0181-32 Lidl 120 tablets — — FDA listed —
Medline 81 mg 53329-0600-67 Medline 120 tablets — — FDA listed —
Aspirin 81mg Enteric Coated 81 mgthis 55154-2607-00 Cardinal 1 tablet — — FDA listed —
Aspirin Low Dose 81 mg 68071-3425-09 NuCare 90 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
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55154-2607-00 You're viewing this 10 BLISTER PACK in 1 BAG (55154-2607-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 2026-07-28 Active

🧭 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 FDA registers it as 55154-2607-0, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 55154-2607-00, written without dashes as 55154260700. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 55154-2607-00, the first segment (55154) is the labeler code FDA assigned to Cardinal Health 107, LLC; the middle segment (2607) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Cardinal Health 107, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cardinal Health 107, 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.

📄 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
🎯 Indications and Usage 37 words ▾

Uses • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headache or other symptoms needing immediate relief.

⏱️ Dosage and Administration 48 words ▾

Directions • drink a full glass of water with each dose • adults and children 12 years and over: take 4 to 8 tablets every 4 hours; not to exceed 48 tablets in 24 hours unless directed by a doctor • children under 12 years: consult a doctor

⚠️ Warnings ~2 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: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock 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 Do not use • if you are allergic to aspirin or any other pain reliever/fever reducer • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis or kidney disease • you are taking a diuretic • you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for: • gout • diabetes • arthritis Stop use and ask a 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 • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • ringing in the ears or a loss of hearing occurs 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📦 Storage and Handling 12 words ▾

Other information • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

🧪 Active Ingredient 11 words ▾

Active ingredient (in each tablet) Aspirin 81mg (NSAID)** **nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients Acrycoat, Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow# 10, Lactose, Microcrystalline Cellulose, Polysorbate 80, Sodium Hydroxide, Talc, Titanium Dioxide, Triethyl Citrate, Yellow Oxide of Iron.

🎯 Purpose 3 words ▾

Purpose Pain Reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 55154-2606-00 · Cardinal 55154-2627-00 · Cardinal →
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.