A+Health Acetaminophen and Ibuprofen Tablets-dual action pain reliever

Manufacturer
Bionpharma Inc. | OrBion Pharmaceuticals Private Limited
Effective date
2024-08-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:56

Label at a glance#

Productdual action pain reliever
Active ingredientIBUPROFEN, ACETAMINOPHEN
Label structure10 sections

Storage and handling

Other information each caplet contains: sodium 3 mg read all warnings and directions before use. store at 20°C to 25°C (68°F to 77°F) avoid excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, USP 250 mg

Ibuprofen, USP 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever

Pain reliever

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

Acetaminophen liver damage warning:

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions

■ do not take more than directed

adults and children 12 years and over■ take 2 caplets every 8 hourswhile symptoms persist
children under 12 years■ ask a doctor

■ do not take more than 6 caplets in 24 hours, unless directed by a doctor

STORAGE AND HANDLING SECTION

Other information

  • each caplet contains: sodium 3 mg
  • read all warnings and directions before use.
  • store at 20°C to 25°C (68°F to 77°F)
  • avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulphate, stearic acid, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?

call toll-free 1-888-235-2466

SPL UNCLASSIFIED SECTION

Do not use with other medicines containing ACETAMINOPHEN; can cause liver damage.

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

***This product is not manufactured or distributed by the owners of Motrin® Dual Action with Tylenol®.

Manufactured for:

BIONPHARMA

Princeton, NJ 08540

MADE IN INDIA

Code: TN/Drugs/TN00002222/2006

R0524

L0000861

949129300

Lot No.:

Exp. Date:

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*** Compare to the active ingredients of Motrin® Dual Action with Tylenol®

NDC 69452-447-22

a+health TM

dual action pain reliever

acetaminophen and ibuprofen

(NSAID) tablets, 250 mg/125 mg

Contains 2 medicines

acetaminophen + ibuprofen

120 Caplets**

**capsule-shaped tablets

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSN1
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCD1
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-447-22dual action pain reliever1 in 1 CARTONTABLET, FILM COATED11
69452-447-22dual action pain reliever120 in 1 BOTTLETABLET, FILM COATED1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-447DUAL ACTION PAIN RELIEVER (ACETAMINOPHEN AND IBUPROFEN) TABLET, FILM COATED [BIONPHARMA INC.]1Current NDC, 2 package rows20240809_1f2f8fcf-bf08-2a21-e063-6394a90a9e71.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-44769452-447-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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 43.

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
A216999-001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORAL2023-08-01

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
2026-09-14 22:38:342026-08A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-0184e616aacf4f…
2026-08-18 06:07:402026-07A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-018072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-019b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216999-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-08-01a50c72e98297…

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
dual action pain relieverACETAMINOPHEN AND IBUPROFENBionpharma Inc.1f2f8fcf-bf08-2a21-e063-6394a90a9e712024-08-08WarningsExact identifier
ndc (package): 69452-447-22
ndc (product): 69452-447
ndc11 (package): 69452044722
spl id: 1f2f8673-7d51-14b0-e063-6394a90afc7f
spl set id: 1f2f8fcf-bf08-2a21-e063-6394a90a9e71

Reported adverse events (FAERS/openFDA)#

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