Acetaminophen and Ibuprofen

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2025-07-03
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-06-01 01:06:38

Label at a glance#

ProductAcetaminophen and Ibuprofen
Active ingredientACETAMINOPHEN, IBUPROFEN
Label structure18 sections

Indications and uses

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

Dosage and administration

­ 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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)                                                                             

Acetaminophen USP 250 mg

Ibuprofen USP 125 mg (NSAID*)

*nonsteroidal anti-in­flammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • ­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

OTC - ASK DOCTOR SECTION

  • ­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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • ­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

OTC - WHEN USING SECTION

•    take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • ­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

Other information

OTC - WHEN USING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose monohydrate, pregelatinized starch (corn), sodium starch glycolate, stearic acid, titanium dioxide, triacetin, yellow iron oxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg (10 Caplets Bottle Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-893-03

CONTAINS 2 MEDICINES
Acetaminophen + Ibuprofen 

Acetaminophen and Ibuprofen (NSAID)
Tablets 250 mg/125 mg

Pain Reliever

10 Caplets*
*Capsule-Shaped Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg (10 Caplets Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg (10 Caplets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg (10 Caplets Bottle Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-893-03

 **Compare to the active ingredients of Advil
Dual Action With Acetaminophen

CONTAINS 2 MEDICINES
Acetaminophen + Ibuprofen
 

Acetaminophen and Ibuprofen (NSAID)
Tablets 250 mg/125 mg

Pain Reliever


8
HOUR
RELIEF

Actual size

10 Caplets*
 *Capsule-Shaped Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg Container Carton (10 Caplets)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg Container Carton (10 Caplets)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg Blister Carton (2 (1 x 2) Caplets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-893-61
                
**Compare to the active ingredients of Advil
Dual Action With Acetaminophen

CONTAINS 2 MEDICINES
Acetaminophen + Ibuprofen
 

Acetaminophen and Ibuprofen (NSAID)
Tablets 250 mg/125 mg

√    Headache                           √    Menstrual Cramps
√    Muscular Aches                  √    Toothache
√    Minor Pain of Arthritis

8
HOUR
RELIEF

Pain Reliever

Each caplet contains Acetaminophen 250 mg
and Ibuprofen 125 mg

Actual size

2 Caplets*
*Capsule-Shaped Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg Blister Carton (2 Caplets)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg Blister Carton (2 Caplets)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSN3
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCD3
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-893-01Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-01Acetaminophen and Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED243
58602-893-02Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-02Acetaminophen and Ibuprofen144 in 1 BOTTLETABLET, FILM COATED1443
58602-893-03Acetaminophen and Ibuprofen10 in 1 BOTTLETABLET, FILM COATED103
58602-893-03Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-07Acetaminophen and Ibuprofen24 in 1 BOTTLETABLET, FILM COATED243
58602-893-07Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-11Acetaminophen and Ibuprofen36 in 1 BOTTLETABLET, FILM COATED363
58602-893-11Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-14Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-14Acetaminophen and Ibuprofen50 in 1 BOTTLETABLET, FILM COATED503
58602-893-21Acetaminophen and Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1003
58602-893-21Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-29Acetaminophen and Ibuprofen150 in 1 BOTTLETABLET, FILM COATED1503
58602-893-29Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-35Acetaminophen and Ibuprofen225 in 1 BOTTLETABLET, FILM COATED2253
58602-893-40Acetaminophen and Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5003
58602-893-41Acetaminophen and Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10003
58602-893-44Acetaminophen and Ibuprofen400 in 1 BOTTLETABLET, FILM COATED4003
58602-893-46Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-46Acetaminophen and Ibuprofen18 in 1 BOTTLE, PLASTICTABLET, FILM COATED183
58602-893-49Acetaminophen and Ibuprofen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED103
58602-893-49Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-51Acetaminophen and Ibuprofen216 in 1 BOTTLE, PLASTICTABLET, FILM COATED2163
58602-893-61Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-61Acetaminophen and Ibuprofen2 in 1 BLISTER PACKTABLET, FILM COATED23
58602-893-62Acetaminophen and Ibuprofen216 in 1 BOTTLETABLET, FILM COATED2163
58602-893-65Acetaminophen and Ibuprofen72 in 1 BOTTLETABLET, FILM COATED723
58602-893-65Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-73Acetaminophen and Ibuprofen20 in 1 BOTTLETABLET, FILM COATED203
58602-893-73Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-78Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-78Acetaminophen and Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED503
58602-893-79Acetaminophen and Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5003
58602-893-80Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-80Acetaminophen and Ibuprofen72 in 1 BOTTLE, PLASTICTABLET, FILM COATED723
58602-893-82Acetaminophen and Ibuprofen18 in 1 BOTTLETABLET, FILM COATED183
58602-893-82Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-84Acetaminophen and Ibuprofen225 in 1 BOTTLE, PLASTICTABLET, FILM COATED2253
58602-893-85Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-85Acetaminophen and Ibuprofen36 in 1 BOTTLE, PLASTICTABLET, FILM COATED363
58602-893-88Acetaminophen and Ibuprofen750 in 1 BOTTLETABLET, FILM COATED7503
58602-893-94Acetaminophen and Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003
58602-893-94Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-95Acetaminophen and Ibuprofen750 in 1 BOTTLE, PLASTICTABLET, FILM COATED7503
58602-893-96Acetaminophen and Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED203
58602-893-96Acetaminophen and Ibuprofen1 in 1 CARTONTABLET, FILM COATED13
58602-893-99Acetaminophen and Ibuprofen400 in 1 BOTTLE, PLASTICTABLET, FILM COATED4003

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218359-001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26c2088c7a36db…
2026-09-14 22:38:342026-08A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-2684e616aacf4f…
2026-08-18 06:07:402026-07A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-268072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218359-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2024-03-26a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENAurohealth LLCb39fb93f-c140-40ab-8247-9559ef6df50a2025-07-03WarningsExact identifier
ndc (package): 58602-893-29
ndc (package): 58602-893-61
ndc (package): 58602-893-46
ndc (package): 58602-893-84
ndc (package): 58602-893-62
ndc (package): 58602-893-02
ndc (package): 58602-893-01
ndc (package): 58602-893-40
ndc (package): 58602-893-51
ndc (package): 58602-893-21
ndc (package): 58602-893-94
ndc (package): 58602-893-35
ndc (package): 58602-893-65
ndc (package): 58602-893-96
ndc (package): 58602-893-41
ndc (package): 58602-893-80
ndc (package): 58602-893-85
ndc (package): 58602-893-88
ndc (package): 58602-893-03
ndc (package): 58602-893-95
ndc (package): 58602-893-44
ndc (package): 58602-893-99
ndc (package): 58602-893-49
ndc (package): 58602-893-82
ndc (package): 58602-893-11
ndc (package): 58602-893-07
ndc (package): 58602-893-79
ndc (package): 58602-893-78
ndc (package): 58602-893-14
ndc (package): 58602-893-73
ndc (product): 58602-893
ndc11 (package): 58602089373
ndc11 (package): 58602089314
ndc11 (package): 58602089303
ndc11 (package): 58602089379
ndc11 (package): 58602089380
ndc11 (package): 58602089340
ndc11 (package): 58602089384
ndc11 (package): 58602089361
ndc11 (package): 58602089349
ndc11 (package): 58602089388
ndc11 (package): 58602089341
ndc11 (package): 58602089395
ndc11 (package): 58602089399
ndc11 (package): 58602089335
ndc11 (package): 58602089365
ndc11 (package): 58602089301
ndc11 (package): 58602089396
ndc11 (package): 58602089385
ndc11 (package): 58602089382
ndc11 (package): 58602089329
ndc11 (package): 58602089362
ndc11 (package): 58602089378
ndc11 (package): 58602089351
ndc11 (package): 58602089344
ndc11 (package): 58602089311
ndc11 (package): 58602089321
ndc11 (package): 58602089346
ndc11 (package): 58602089302
ndc11 (package): 58602089307
ndc11 (package): 58602089394
spl id: 4c479545-4af0-49b7-8a62-632a97c5c637
spl set id: b39fb93f-c140-40ab-8247-9559ef6df50a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.