FDA.reportPublic FDA data

Kroger Co. Acetaminophen and Ibuprofen Tablets Drug Facts

Manufacturer
Kroger Company
Effective date
2026-06-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-06-11 05:10:33

Label at a glance#

Productacetaminophen and ibuprofen
Active ingredientACETAMINOPHEN, IBUPROFEN
Label structure8 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

Storage and handling

• 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)

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Ibuprofen 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

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

STORAGE AND HANDLING SECTION

  • 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)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kroger® health

COMPARE TO THE ACTIVE INGREDIENTS IN ADVIL® DUAL ACTION

CONTAINS 2 MEDICINES

DUAL ACTION

8-HOUR RELIEF

Acetaminophen and Ibuprofen

Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets

PAIN RELIEVER

72 CAPLETS§

§CAPSULE-SHAPED TABLETS

ACTUAL SIZE

krogerhealth-acetaminophen-and-ibuprofen-carton-image.jpg
krogerhealth-acetaminophen-and-ibuprofen-carton-image.jpg

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

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-72030142-720-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
IBUPROFENWK2XYI10QMACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
SUCRALOSE96K6UQ3ZD4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-07-17full-release2026-06-01 01:08:29

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
A214836-001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28

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 22:38:342026-08A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2884e616aacf4f…
2026-08-18 06:07:402026-07A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-288072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214836-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-02-28a50c72e98297…

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, IBUPROFENKroger Companye6c0cca6-812e-4bea-86b0-e15b10f3f0d42026-06-04WarningsExact identifier
ndc (package): 30142-720-23
ndc (product): 30142-720
ndc11 (package): 30142072023
spl id: dd1540cd-c51e-487f-8457-8b45f7aa13cc
spl set id: e6c0cca6-812e-4bea-86b0-e15b10f3f0d4

Reported adverse events (FAERS/openFDA)#

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