Acetaminophen and Ibuprofen Back Pain - Aurohealth LLC | APL HEALTHCARE LIMITED

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2026-04-28
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 01:55:12

Label at a glance#

ProductAcetaminophen and Ibuprofen Back Pain
Active ingredientACETAMINOPHEN, IBUPROFEN
Label structure18 sections

Indications and uses

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

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:­
    • backache
    • muscular aches
    • minor pain of arthritis
    • headache
    • toothache
    • menstrual cramps

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 58602-895-03

CONTAINS 2 MEDICINES
Acetaminophen + Ibuprofen

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

BACK PAIN

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 58602-895-03

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

CONTAINS 2 MEDICINES
Acetaminophen + Ibuprofen

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

 
BACK PAIN

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 58602-895-61

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

CONTAINS 2 MEDICINES
Acetaminophen + Ibuprofen

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

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

BACK PAIN

Pain Reliever

Each caplet contains Acetaminophen 250 mg
and Ibuprofen 125 mg

8
HOUR
RELIEF

Actual Size

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSN2
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCD2
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSY2

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
58602-895-01Acetaminophen and Ibuprofen Back Pain24 in 1 BOTTLE, PLASTICTABLET, FILM COATED242
58602-895-01Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-03Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-03Acetaminophen and Ibuprofen Back Pain10 in 1 BOTTLETABLET, FILM COATED102
58602-895-07Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-07Acetaminophen and Ibuprofen Back Pain24 in 1 BOTTLETABLET, FILM COATED242
58602-895-11Acetaminophen and Ibuprofen Back Pain36 in 1 BOTTLETABLET, FILM COATED362
58602-895-11Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-14Acetaminophen and Ibuprofen Back Pain50 in 1 BOTTLETABLET, FILM COATED502
58602-895-14Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-21Acetaminophen and Ibuprofen Back Pain100 in 1 BOTTLETABLET, FILM COATED1002
58602-895-21Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-29Acetaminophen and Ibuprofen Back Pain150 in 1 BOTTLETABLET, FILM COATED1502
58602-895-29Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-35Acetaminophen and Ibuprofen Back Pain225 in 1 BOTTLETABLET, FILM COATED2252
58602-895-40Acetaminophen and Ibuprofen Back Pain500 in 1 BOTTLETABLET, FILM COATED5002
58602-895-41Acetaminophen and Ibuprofen Back Pain1000 in 1 BOTTLETABLET, FILM COATED10002
58602-895-44Acetaminophen and Ibuprofen Back Pain400 in 1 BOTTLETABLET, FILM COATED4002
58602-895-46Acetaminophen and Ibuprofen Back Pain18 in 1 BOTTLE, PLASTICTABLET, FILM COATED182
58602-895-46Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-49Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-49Acetaminophen and Ibuprofen Back Pain10 in 1 BOTTLE, PLASTICTABLET, FILM COATED102
58602-895-51Acetaminophen and Ibuprofen Back Pain216 in 1 BOTTLE, PLASTICTABLET, FILM COATED2162
58602-895-61Acetaminophen and Ibuprofen Back Pain2 in 1 BLISTER PACKTABLET, FILM COATED22
58602-895-61Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-62Acetaminophen and Ibuprofen Back Pain216 in 1 BOTTLETABLET, FILM COATED2162
58602-895-65Acetaminophen and Ibuprofen Back Pain72 in 1 BOTTLETABLET, FILM COATED722
58602-895-65Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-73Acetaminophen and Ibuprofen Back Pain20 in 1 BOTTLETABLET, FILM COATED202
58602-895-73Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-78Acetaminophen and Ibuprofen Back Pain50 in 1 BOTTLE, PLASTICTABLET, FILM COATED502
58602-895-78Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-79Acetaminophen and Ibuprofen Back Pain500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5002
58602-895-80Acetaminophen and Ibuprofen Back Pain72 in 1 BOTTLE, PLASTICTABLET, FILM COATED722
58602-895-80Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-82Acetaminophen and Ibuprofen Back Pain18 in 1 BOTTLETABLET, FILM COATED182
58602-895-82Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-84Acetaminophen and Ibuprofen Back Pain225 in 1 BOTTLE, PLASTICTABLET, FILM COATED2252
58602-895-85Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-85Acetaminophen and Ibuprofen Back Pain36 in 1 BOTTLE, PLASTICTABLET, FILM COATED362
58602-895-88Acetaminophen and Ibuprofen Back Pain750 in 1 BOTTLETABLET, FILM COATED7502
58602-895-94Acetaminophen and Ibuprofen Back Pain100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
58602-895-94Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-95Acetaminophen and Ibuprofen Back Pain750 in 1 BOTTLE, PLASTICTABLET, FILM COATED7502
58602-895-96Acetaminophen and Ibuprofen Back Pain1 in 1 CARTONTABLET, FILM COATED12
58602-895-96Acetaminophen and Ibuprofen Back Pain20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
58602-895-99Acetaminophen and Ibuprofen Back Pain400 in 1 BOTTLE, PLASTICTABLET, FILM COATED4002

Products#

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

DailyMed product names page 1 of 1 · 13 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#

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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 Ibuprofen Back PainACETAMINOPHEN AND IBUPROFENAurohealth LLC62d7ce90-63a4-4383-87c9-3a458eac29bf2026-04-28WarningsExact identifier
ndc (package): 58602-895-03
ndc (package): 58602-895-11
ndc (package): 58602-895-65
ndc (package): 58602-895-73
ndc (package): 58602-895-61
ndc (package): 58602-895-79
ndc (package): 58602-895-62
ndc (package): 58602-895-84
ndc (package): 58602-895-94
ndc (package): 58602-895-95
ndc (package): 58602-895-80
ndc (package): 58602-895-78
ndc (package): 58602-895-82
ndc (package): 58602-895-46
ndc (package): 58602-895-21
ndc (package): 58602-895-41
ndc (package): 58602-895-07
ndc (package): 58602-895-40
ndc (package): 58602-895-14
ndc (package): 58602-895-35
ndc (package): 58602-895-99
ndc (package): 58602-895-51
ndc (package): 58602-895-85
ndc (package): 58602-895-01
ndc (package): 58602-895-88
ndc (package): 58602-895-29
ndc (package): 58602-895-96
ndc (package): 58602-895-49
ndc (package): 58602-895-44
ndc (product): 58602-895
ndc11 (package): 58602089578
ndc11 (package): 58602089503
ndc11 (package): 58602089595
ndc11 (package): 58602089540
ndc11 (package): 58602089562
ndc11 (package): 58602089573
ndc11 (package): 58602089596
ndc11 (package): 58602089599
ndc11 (package): 58602089594
ndc11 (package): 58602089501
ndc11 (package): 58602089511
ndc11 (package): 58602089582
ndc11 (package): 58602089514
ndc11 (package): 58602089551
ndc11 (package): 58602089546
ndc11 (package): 58602089549
ndc11 (package): 58602089561
ndc11 (package): 58602089584
ndc11 (package): 58602089541
ndc11 (package): 58602089588
ndc11 (package): 58602089565
ndc11 (package): 58602089507
ndc11 (package): 58602089579
ndc11 (package): 58602089544
ndc11 (package): 58602089580
ndc11 (package): 58602089535
ndc11 (package): 58602089585
ndc11 (package): 58602089529
ndc11 (package): 58602089521
spl id: 358fae0b-3a56-4ffa-ba09-de83cd8200a5
spl set id: 62d7ce90-63a4-4383-87c9-3a458eac29bf

Reported adverse events (FAERS/openFDA)#

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