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good sense dual action Acetaminophen, Ibuprofen 250 mg; 125 mg Tablet, Film Coated, 144-count — NDC 00113-5300-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

good sense dual action Acetaminophen, Ibuprofen 250 mg; 125 mg Tablet, Film Coated, 144-count — NDC 0113-5300-16 (Billing 00113-5300-16)

by L Perrigo Company · 1 BOTTLE in 1 CARTON / 144 TABLET, FILM COATED in 1 BOTTLE

This is a package of 144 tablets of good sense dual action Acetaminophen, Ibuprofen 250 mg; 125 mg Tablet, Film Coated from L Perrigo Company, marketed since Mar 2023 and currently FDA-listed; retail pharmacies pay about $0.1071 per tablet (NADAC). It is the main listing for this product, which comes in 3 package sizes.

NDC 00113-5300-16
🏷️ FDA NDC (as labeled) 0113-5300-16 billing pads the labeler segment with a zero
This package
Contains144-count Cost per ea$0.1071 NADAC Per package$15.42 / 144 tablets Pack sizes3 compare ↓
Main listing for product 0113-5300 · Also comes in: 36 tablets 0113-5300-68 216 tablets 0113-5300-01
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 0113-5300-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0113 labeler · 5300 product · 16 package
Package marketed since
Mar 1, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
144 EA per package
Barcode (UPC-A, from the NDC)
3 0113530016 5
FDA record last changed
Aug 20, 2026
⚠️
Other active recalls for Acetaminophen, Ibuprofen (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0347-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0113-5300-16
Product NDC 0113-5300
11-digit billing NDC 00113530016
NCPDP billing unit EA — each (per item)
RxCUI 2387532
UNII 362O9ITL9D, WK2XYI10QM
Application # ANDA214836
SPL Set ID b117358c-f4ca-4ea8-95ee-88a42cc05040
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 2023-03-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; IBUPROFEN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 080857
GCN 47839
HICL code 012981
Ingredient (HICL) Ibuprofen/Acetaminophen
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S2
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On Joints
HIC3 code S2Y
Therapeutic class — specific (HIC3) Nsaid Analgesic And Non-Salicylate Analgesic Comb
AHFS code 28:08.04.04
AHFS class Reversible Cox-1/Cox-2 Inhibitors
FDB label name GS DUAL ACTION PAIN 250-125 MG
FDB brand name Dual Action Pain Reliever
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 080857
  • GCN: 47839
  • HICL (First Databank): 012981
  • AHFS class code: 28:08.04.04
  • RxCUI (RxNorm): 2387532
Why two NDCs? The FDA registers this code as 0113-5300-16 — a 4-4-2 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 labeler segment → 00113-5300-16. 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.

Clinical

Label name GS DUAL ACTION PAIN 250-125 MG Ingredient Ibuprofen/Acetaminophen
📖 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
  • Great question — it's intentional. Acetaminophen and ibuprofen work through completely different pathways in the body, so together they can give you broader, more effective pain re...
  • Why does this combine two pain relievers? Is that safe?
  • It depends on what you're taking. The ibuprofen in this product can interact with blood thinners like warfarin, blood pressure medicines like ACE inhibitors or ARBs, diuretics, dig...
  • Can I take this with my other medications?
📖 Read our full Acetaminophen / Ibuprofen guide →
2
Nutrient depletion considerations

Acetaminophen, Ibuprofen may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen, Ibuprofen 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 eaPer package
Retail pharmacies payNADAC · weekly $0.107 $15.42 / 144 tablets
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.107 $0.084
▲ Up 16% over the last 10 months.
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 Per unit Per pack Marketing startMarketing endStatus
00113-5300-16 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 144 TABLET, FILM COATED in 1 BOTTLE $0.1071 / ea $15.42 2023-03-01 — Active
00113-5300-68 0113-5300-68 1 BOTTLE in 1 CARTON / 36 TABLET, FILM COATED in 1 BOTTLE $0.1071 / ea $3.86 2023-03-01 — Active
00113-5300-01 0113-5300-01 1 BOTTLE in 1 CARTON / 216 TABLET, FILM COATED in 1 BOTTLE — — 2026-05-07 — Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1071 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 144-count package — 1 bottle in 1 carton / 144 tablet, film coated in 1 bottle.
How does this package differ from NDC 00113-5300-68?
Both are good sense dual action Acetaminophen, Ibuprofen 250 mg; 125 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 144-count one, while NDC 00113-5300-68 is the 36 tablets package.
What NDC number is used to bill for this package of good sense dual action Acetaminophen, Ibuprofen 250 mg; 125 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 00536-1376-36 RUGBY 36 tablets $0.084 — Availability likely save 21%
good sense dual action 250 mg/1; 125 mgthis 00113-5300-16 L 144 tablets $0.107 — Availability likely —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 46122-0742-68 AMERISOURCE 36 tablets $0.107 — Availability likely —
Acetaminophen and Ibuprofen 125 mg/1; 250 mg 46122-0818-61 AMERISOURCE 80 tablets $0.107 — Availability likely —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 70000-0622-01 LEADER/ 18 tablets $0.107 — Availability likely —
Leader Dual Action Pain Reliever 250 mg/1; 125 mg 70000-0737-01 Cardinal 18 tablets $0.107 — Availability likely —
foster and thrive dual action 250 mg/1; 125 mg 70677-1274-01 Strategic 36 tablets $0.107 — Availability likely —
dual action pain reliever 125 mg/1; 250 mg 83324-0149-36 CHAIN 36 tablets $0.107 — 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 mg 51672-4258-01 Sun 216 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 —
Acetaminophen and Ibuprofen 250 mg/1; 125 mg 50844-0598-14 L.N.K. 500 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
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.

What it looks like

Color Yellow
ShapeOval
ImprintI;I
Size14 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 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient 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 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 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 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 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 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statescolloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, ferric oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, sucralose, 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

LabelerL Perrigo Company
Application holderL PERRIGO CO
FDA applicationANDA214836 (ANDA)
Labeler code00113
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio17 products on file

More NDCs from L Perrigo Company labeler code 00113

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 📄 When Using This Product 📄 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 27 words ▾

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

⏱️ Dosage and Administration 47 words ▾

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

⚠️ Warnings ~3 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 caplets 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.

Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • if you have ever had an allergic reaction to acetaminophen or any other pain reliever • right before or after heart surgery Ask a doctor before use if • you have liver disease • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • you are taking a diuretic Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug When using this product • take with food or milk if stomach upset occurs Stop use and ask a doctor if • 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 • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • pain gets worse or lasts more than 10 days • redness or swelling is present in the painful area • any new symptoms appear If pregnant or breast-feeding, ask a health professional before use.

It is especially important not to use ibuprofen 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 right away (1-800-222-1222).

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 24 words ▾

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

🧪 Active Ingredient 15 words ▾

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

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, ferric oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

🎯 Purpose 3 words ▾

Purposes Pain reliever

📄 Do Not Use 51 words ▾

Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist • if you have ever had an allergic reaction to acetaminophen or any other pain reliever • right before or after heart surgery

📄 Ask a Doctor Before Use If 64 words ▾

Ask a doctor before use if • you have liver disease • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • you are taking a diuretic

📄 Ask a Doctor or Pharmacist Before Use If 40 words ▾

Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug

📄 When Using This Product 14 words ▾

When using this product • take with food or milk if stomach upset occurs

📄 Stop Use and Ask a Doctor If 94 words ▾

Stop use and ask a doctor if • 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 • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • pain gets worse or lasts more than 10 days • redness or swelling is present in the painful area • any new symptoms appear

🤰 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 ibuprofen 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 right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-719-9260

📄 Package Label / Principal Display Panel 42 words ▾

Package/Label Principal Display Panel GOODSENSE ® Acetaminophen plus Ibuprofen CONTAINS 2 MEDICINES Dual Action Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever 216 Caplets** **Capsule-Shaped Tablets Compare to active ingredients of Advil ® Dual Action 100% SATISFACTION GUARANTEED goodsense-dual-action-carton-image.jpg

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 good sense dual action (this brand).

Top reported reactions

Nausea2
Back Injury1
Back Pain1
Bone Disorder1
Cartilage Injury1
Constipation1
Diarrhoea1

Reporter sex

3 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2025 2026 1 1
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.
← 00113-5299-16 · L. 00113-5305-40 · L. →
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.