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Acetaminophen 250 mg and Ibuprofen 125 250 mg; 125 mg Tablet, 72-count — NDC 51672-4258-04 package photo

Acetaminophen 250 mg and Ibuprofen 125 250 mg; 125 mg Tablet, 72-count

by Sun Pharmaceutical Industries, Inc. · 1 BOTTLE in 1 CARTON (51672-4258-4) / 72 TABLET in 1 BOTTLE
NDC 51672-4258-04
🏷️ FDA NDC (as labeled) 51672-4258-4 billing pads the package segment with a zero
This package
Contains72-count Pack sizes2 compare ↓
Also comes in: 216 tablets 51672-4258-01
OTC Generic On market Non-controlled
🗂️ Data synced Jul 24, 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) 51672-4258-4
Product NDC 51672-4258
11-digit billing NDC 51672425804
NCPDP billing unit EA — each (per item)
RxCUI 2387532
UNII 362O9ITL9D, WK2XYI10QM
Application # ANDA219053
SPL Set ID 2a31a975-72f9-2a16-e063-6394a90a8149
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-15
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; IBUPROFEN
Why two NDCs? The FDA registers this code as 51672-4258-4 — 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 → 51672-4258-04. 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 Anilides class.

Drug family (ATC) Anilides
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

LabelerSun Pharmaceutical Industries, Inc.
Application holderTARO PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA219053 (ANDA)
Labeler code51672
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio889 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

📖 What it is MedlinePlus · NLM

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • That's a smart question. The idea behind combining them is that they work through different pathways, so together they may give you broader pain relief. For everyday mild to modera...
  • Can I take this combination instead of just acetaminophen or just ibuprofen?
  • You'll want to be cautious. Drinking 3 or more alcoholic beverages a day while using this product significantly raises your risk of liver damage from the acetaminophen, and also in...
  • Is it safe to take this with a drink or two?
📖 Read our full Acetaminophen / Ibuprofen guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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
ShapeOval
ImprintT;II
Size15 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 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 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 R8WTH25YS2
    Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
  • 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 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 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 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.

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

The official label also statescolloidal silicone dioxide, croscarmellose sodium, ferric oxide yellow, ferrosoferric oxide, glyceryl dibehenate, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized starch, 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.

💲 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.
Try another pack size: 216 tablets
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
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 00536-1376-36 RUGBY 36 tablets $0.084 — Availability likely —
good sense dual action 250 mg/1; 125 mg 00113-5300-16 L 144 tablets $0.106 — Availability likely —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 46122-0742-68 AMERISOURCE 36 tablets $0.106 — Availability likely —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 46122-0818-61 AMERISOURCE 80 tablets $0.106 — Availability likely —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 70000-0622-01 LEADER/ 18 tablets $0.106 — Availability likely —
Leader Dual Action Pain Reliever 250 mg/1; 125 mg 70000-0737-01 Cardinal 18 tablets $0.106 — Availability likely —
foster and thrive dual action 250 mg/1; 125 mg 70677-1274-01 Strategic 36 tablets $0.106 — Availability likely —
dual action pain reliever 125 mg/1; 250 mg 83324-0149-36 CHAIN 36 tablets $0.106 — Availability likely —
Good Sense Dual Action Back Pain 250 mg/1; 125 mg 00113-5299-16 L. 144 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 00363-4081-78 WALGREEN 80 tablets — — FDA listed —
dual pain reliever 250 mg/1; 125 mg 00363-5220-01 Walgreen 216 tablets — — FDA listed —
Dual Back Pain Reliever 250 mg/1; 125 mg 00363-6199-23 Walgreen 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 00363-9131-16 WALGREENS 216 tablets — — FDA listed —
ADVIL DUAL ACTION WITH ACETAMINOPHEN Back Pain 125 mg/1; 250 mg 00573-0145-02 Haleon 2 tablets — — FDA listed —
Advil Dual Action With Acetaminophen 125 mg/1; 250 mg 00573-0147-18 Haleon 18 tablets — — FDA listed —
Dual Action Pain Relief 125 mg/1; 250 mg 11673-0924-75 TARGET 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen (NSAID) 125 mg/1; 250 mg 11822-1131-04 RITE 144 tablets — — FDA listed —
dual action 250 mg/1; 125 mg 11822-5777-00 Rite 36 tablets — — FDA listed —
Dual Action 250 mg/1; 125 mg 21130-0716-08 BETTER 18 tablets — — FDA listed —
Acetaminophen 250 mg and Ibuprofen 125 mg 250 mg/1; 125 mg 25000-0080-07 MARKSANS 90 tablets — — FDA listed —
acetaminophen and ibuprofen 250 mg/1; 125 mg 30142-0720-23 Kroger 72 tablets — — FDA listed —
equaline dual action pain reliever 250 mg/1; 125 mg 41163-0103-68 United 36 tablets — — FDA listed —
Dual Action 250 mg/1; 125 mg 41226-0716-49 KROGER 144 tablets — — FDA listed —
Dual Action 250 mg/1; 125 mg 42507-0540-72 HyVee 72 tablets — — FDA listed —
Acetaminophen 250 mg and Ibuprofen 125 mg 125 mg/1; 250 mg 43598-0052-05 Dr. 500 tablets — — FDA listed —
Dual Action Pain Relief 250 mg/1; 125 mg 49483-0716-49 TIME 144 tablets — — FDA listed —
Motrin Dual Action With Tylenol 125 mg/1; 250 mg 50580-0208-02 Kenvue 20 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 51316-0131-36 CVS 36 tablets — — FDA listed —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 51316-0132-72 CVS 72 tablets — — FDA listed —
Acetaminophen 250 mg and Ibuprofen 125 mg 250 mg/1; 125 mgthis 51672-4258-04 Sun 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 53943-0034-76 DISCOUNT 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 55319-0139-36 Family 36 tablets — — FDA listed —
DG health dual pain reliever 250 mg/1; 125 mg 55910-0441-16 Dolgencorp 144 tablets — — FDA listed —
dg health dual back pain reliever 250 mg/1; 125 mg 55910-0508-23 Dolgencorp 72 tablets — — FDA listed —
dual action 250 mg/1; 125 mg 56062-0530-23 Publix 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 58602-0893-01 Aurohealth 24 tablets — — FDA listed —
Acetaminophen and Ibuprofen Back Pain 250 mg/1; 125 mg 58602-0895-01 Aurohealth 24 tablets — — FDA listed —
Advil Dual Action with Acetaminophen, Travel BASIX 125 mg/1; 250 mg 66715-6401-02 Lil' 2 tablets — — FDA listed —
Advil Dual Action with Acetaminophen 125 mg/1; 250 mg 66715-9601-03 Lil' 2 tablets — — FDA listed —
Advil Dual Action With Acetaminophen 125 mg/1; 250 mg 67751-0211-01 Navajo 2 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 69452-0394-64 Bionpharma 216 tablets — — FDA listed —
dual action pain reliever 125 mg/1; 250 mg 69452-0446-23 Bionpharma 144 tablets — — FDA listed —
dual action pain reliever 125 mg/1; 250 mg 69452-0447-22 Bionpharma 120 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 69452-0469-22 BIONPHARMA 120 tablets — — FDA listed —
Pain Reliever 250 mg/1; 125 mg 69842-0675-23 CVS 72 tablets — — FDA listed —
Aacetaminophen and Ibuprofen 250 mg/1; 125 mg 69848-0588-72 GRANULES 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 70010-0131-26 Granules 18 tablets — — FDA listed —
Acetaminophen and Ibuprofen Back Pain 250 mg/1; 125 mg 70010-0213-26 Granules 18 tablets — — FDA listed —
Acetaminophen 250 mg/1; 125 mg 70038-0131-36 RAONBIO 36 tablets — — FDA listed —
Acetaminophen 250 mg and Ibuprofen 125 mg 250 mg/1; 125 mg 70264-0040-12 R 2 tablets — — FDA listed —
Basic Care Dual Action 250 mg/1; 125 mg 72288-0530-01 Amazon.com 216 tablets — — FDA listed —
Dual Action 250 mg/1; 125 mg 72288-0542-01 Amazon.com 216 tablets — — FDA listed —
Acetaminophen and Ibuprofen (NSAID) 125 mg/1; 250 mg 72476-0131-72 RETAIL 72 tablets — — FDA listed —
Careone Dual Action 250 mg/1; 125 mg 72476-0231-23 Retail 72 tablets — — FDA listed —
Acetaminophen, Ibuprofen 125 mg/1; 250 mg 72657-0157-05 GLENMARK 500 tablets — — FDA listed —
Dual Action 125 mg/1; 250 mg 75907-0158-14 Dr. 144 tablets — — FDA listed —
topcare dual action 250 mg/1; 125 mg 76162-0501-16 Topco 144 tablets — — FDA listed —
Topcare Dual Action Back Pain 250 mg/1; 125 mg 76162-0520-23 Topco 72 tablets — — FDA listed —
Dual Action Back Pain Reliever 250 mg/1; 125 mg 79481-0152-00 Meijer, 72 tablets — — FDA listed —
dual pain reliever 250 mg/1; 125 mg 79481-0503-00 Meijer, 36 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 79481-6501-07 Meijer 80 tablets — — FDA listed —
equate pain reliever 250 mg/1; 125 mg 79903-0148-36 WALMART 36 tablets — — FDA listed —
equate dual pain reliever 250 mg/1; 125 mg 79903-0243-36 WALMART 36 tablets — — FDA listed —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 79903-0244-44 WAL-MART 144 tablets — — FDA listed —
equate dual back pain reliever 250 mg/1; 125 mg 79903-0326-72 WALMART 72 tablets — — FDA listed —
Acetaminophen and Ibuprofen (NSAID) 125 mg/1; 250 mg 79903-0931-44 Wal-Mart 144 tablets — — FDA listed —
dual action pain reliever 125 mg/1; 250 mg 83324-0178-44 CHAIN 144 tablets — — FDA listed —
Period Pills by Biikay 250 mg/1; 125 mg 85576-0101-36 Kai 36 tablets — — FDA listed —
good sense dual action 250 mg/1; 125 mg 85766-0044-36 Sportpharm 36 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🔬 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 Acetaminophen 250 mg and Ibuprofen 125 mg (this brand).

Top reported reactions

Drug Effective For Unapproved Indication30
Therapeutic Product Effect Incomplete27
Drug Effect Less Than Expected15
Underdose13
Overdose10
Drug Ineffective For Unapproved Indication8
Hypersensitivity7

Age at onset

Adult156

Reporter sex

0 reports
Male · 30%
Female · 70%

Serious outcomes

Hospitalization5
Life-threatening2
Death1
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 55 9
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51672-4258-01 1 BOTTLE in 1 CARTON (51672-4258-1) / 216 TABLET in 1 BOTTLE 2026-03-15 Active
51672-4258-04 You're viewing this 1 BOTTLE in 1 CARTON (51672-4258-4) / 72 TABLET in 1 BOTTLE 2026-03-15 Active

Pack size FAQ

What quantity is in NDC 51672-4258-04?
NDC 51672-4258-04 is a 72-count package — 1 bottle in 1 carton / 72 tablet in 1 bottle.
What is the difference between NDC 51672-4258-04 and NDC 51672-4258-01?
Both are Acetaminophen 250 mg and Ibuprofen 125 250 mg; 125 mg Tablet — the drug itself is identical. NDC 51672-4258-04 is the 72-count package, while NDC 51672-4258-01 is the 216 tablets package.
What NDC number is used to bill for this package of Acetaminophen 250 mg and Ibuprofen 125 250 mg; 125 mg Tablet?
Bill NDC 51672-4258-04 — the 11-digit billing format is 51672425804. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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

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 51672-4258-4, 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: 51672-4258-04, written without dashes as 51672425804. 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 51672-4258-04, the first segment (51672) is the labeler code FDA assigned to Sun Pharmaceutical Industries, Inc.; the middle segment (4258) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 216 tablets (51672-4258-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, Inc. 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 21 words ▾

Uses • temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis

⏱️ Dosage and Administration 49 words ▾

Directions • do not take more than directed adults and children 12 years and over • take 2 tablets every 8 hours while symptoms persist children under 12 years • ask a doctor • do not take more than 6 tablets in 24 hours, unless directed by a doctor

⚠️ Warnings ~1 min read ▾

Warnings Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: • with other drugs containing acetaminophen • more than 6 tablets in 24 hours, which is the maximum daily amount for this product • 3 or more alcoholic drinks every day while using this product Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If skin reaction occurs, stop use and seek medical help right away.

NSAID allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. NSAID stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

📦 Storage and Handling 28 words ▾

Other information • read all warnings and directions before use. Keep carton. • store at 20 to 25ºC (68 to 77ºF) • avoid excessive heat above 40°C (104°F)

🧪 Active Ingredient 17 words ▾

Active ingredients (in each tablet) Acetaminophen, USP 250 mg Ibuprofen, USP 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients colloidal silicone dioxide, croscarmellose sodium, ferric oxide yellow, ferrosoferric oxide, glyceryl dibehenate, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide

🎯 Purpose 5 words ▾

Purposes Pain reliever Pain reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51672-4256-09 · Sun 51672-5263-01 · Sun →
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.