Indications and uses
temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis
temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis
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
Active ingredients (in each caplet)
Acetaminophen USP 250 mg
Ibuprofen USP 125 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain reliever
Acetaminophen liver damage warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
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:
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:
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.
• take with food or milk if stomach upset occurs
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| adults and children 12 years and over |
|
| children under 12 years |
|
colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose monohydrate, pregelatinized starch (corn), sodium starch glycolate, stearic acid, titanium dioxide, triacetin, yellow iron oxide
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
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
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
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
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58602-893-01 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-01 | Acetaminophen and Ibuprofen | 24 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 24 | 3 | |
| 58602-893-02 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-02 | Acetaminophen and Ibuprofen | 144 in 1 BOTTLE | TABLET, FILM COATED | 144 | 3 | |
| 58602-893-03 | Acetaminophen and Ibuprofen | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 3 | |
| 58602-893-03 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-07 | Acetaminophen and Ibuprofen | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 3 | |
| 58602-893-07 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-11 | Acetaminophen and Ibuprofen | 36 in 1 BOTTLE | TABLET, FILM COATED | 36 | 3 | |
| 58602-893-11 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-14 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-14 | Acetaminophen and Ibuprofen | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 3 | |
| 58602-893-21 | Acetaminophen and Ibuprofen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 3 | |
| 58602-893-21 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-29 | Acetaminophen and Ibuprofen | 150 in 1 BOTTLE | TABLET, FILM COATED | 150 | 3 | |
| 58602-893-29 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-35 | Acetaminophen and Ibuprofen | 225 in 1 BOTTLE | TABLET, FILM COATED | 225 | 3 | |
| 58602-893-40 | Acetaminophen and Ibuprofen | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 3 | |
| 58602-893-41 | Acetaminophen and Ibuprofen | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 3 | |
| 58602-893-44 | Acetaminophen and Ibuprofen | 400 in 1 BOTTLE | TABLET, FILM COATED | 400 | 3 | |
| 58602-893-46 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-46 | Acetaminophen and Ibuprofen | 18 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 18 | 3 | |
| 58602-893-49 | Acetaminophen and Ibuprofen | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | 3 | |
| 58602-893-49 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-51 | Acetaminophen and Ibuprofen | 216 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 216 | 3 | |
| 58602-893-61 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-61 | Acetaminophen and Ibuprofen | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 3 | |
| 58602-893-62 | Acetaminophen and Ibuprofen | 216 in 1 BOTTLE | TABLET, FILM COATED | 216 | 3 | |
| 58602-893-65 | Acetaminophen and Ibuprofen | 72 in 1 BOTTLE | TABLET, FILM COATED | 72 | 3 | |
| 58602-893-65 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-73 | Acetaminophen and Ibuprofen | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 3 | |
| 58602-893-73 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-78 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-78 | Acetaminophen and Ibuprofen | 50 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 50 | 3 | |
| 58602-893-79 | Acetaminophen and Ibuprofen | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | 3 | |
| 58602-893-80 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-80 | Acetaminophen and Ibuprofen | 72 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 72 | 3 | |
| 58602-893-82 | Acetaminophen and Ibuprofen | 18 in 1 BOTTLE | TABLET, FILM COATED | 18 | 3 | |
| 58602-893-82 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-84 | Acetaminophen and Ibuprofen | 225 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 225 | 3 | |
| 58602-893-85 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-85 | Acetaminophen and Ibuprofen | 36 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 36 | 3 | |
| 58602-893-88 | Acetaminophen and Ibuprofen | 750 in 1 BOTTLE | TABLET, FILM COATED | 750 | 3 | |
| 58602-893-94 | Acetaminophen and Ibuprofen | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | 3 | |
| 58602-893-94 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-95 | Acetaminophen and Ibuprofen | 750 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 750 | 3 | |
| 58602-893-96 | Acetaminophen and Ibuprofen | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | 3 | |
| 58602-893-96 | Acetaminophen and Ibuprofen | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 58602-893-99 | Acetaminophen and Ibuprofen | 400 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 400 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58602-893 | 58602-893-03, 58602-893-82, 58602-893-73, 58602-893-07, 58602-893-11, 58602-893-14, 58602-893-65, 58602-893-21, 58602-893-29, 58602-893-62, 58602-893-35, 58602-893-44, 58602-893-40, 58602-893-88, 58602-893-41, 58602-893-49, 58602-893-46, 58602-893-96, 58602-893-01, 58602-893-85, 58602-893-78, 58602-893-80, 58602-893-94, 58602-893-51, 58602-893-84, 58602-893-99, 58602-893-79, 58602-893-95, 58602-893-61, 58602-893-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| IBUPROFEN | WK2XYI10QM | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSE 2910 (15 MPA.S) | 36SFW2JZ0W | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| PALMITOSTEARIC ACID | Q8Y7S3B85M | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218359-001 | ACETAMINOPHEN AND IBUPROFEN | ACETAMINOPHEN; IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | 8072bd15b7f6… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218359-001 | ACETAMINOPHEN AND IBUPROFEN | 250MG;125MG | TABLET / ORAL | 2024-03-26 | a50c72e98297… |
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.
Adverse event summaries are temporarily unavailable. Other product information remains available.