FDA.reportPublic FDA data

716R Albertsons 21130-716 Acetaminophen and Ibuprofen Tablets 250 mg/ 125 mg

Manufacturer
BETTER LIVING BRANDS, LLC | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2024-08-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:17:40

Label at a glance#

ProductDual Action
Active ingredientACETAMINOPHEN, IBUPROFEN
Label structure9 sections

Storage and handling

Other information read all warnings and directions before use. Keep carton. store at 20-25ºC (68-77ºF) avoid excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purposes

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:

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.

OTC - DO NOT USE SECTION

Do not use

  • 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • 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

OTC - WHEN USING SECTION

When using this product

  • take with food or milk if stomach upset occurs

OTC - STOP USE SECTION

Stop use and ask a doctor if

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 (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.

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

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

INACTIVE INGREDIENT SECTION

Inactive ingredientscolloidal anhydrous silica, corn starch, croscarmellose sodium, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, povidone, red iron oxide, titanium dioxide, triacetin, yellow iron oxide.

OTC - QUESTIONS SECTION

Questions or comments?Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

716R_Albertsons_IFC_72ct716R_Albertsons_IFC_72ct716R_Albertsons_IFC_18ct716R_Albertsons_IFC_18ct716R-alb-ibupara-72ct-label716R-alb-ibupara-72ct-label716R-alb-ibupara-18ct-label716R-alb-ibupara-18ct-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletPSN4
2387532acetaminophen 250 MG / ibuprofen 125 MG Oral TabletSCD4
2387532APAP 250 MG / ibuprofen 125 MG Oral TabletSY4

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
21130-716-08Dual Action1 in 1 CARTONTABLET14
21130-716-08Dual Action18 in 1 BOTTLETABLET184
21130-716-75Dual Action1 in 1 CARTONTABLET14
21130-716-75Dual Action72 in 1 BOTTLETABLET724

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-716DUAL ACTION (ACETAMINOPHEN, IBUPROFEN) TABLET [BETTER LIVING BRANDS, LLC]4Current NDC, 4 package rows20240823_f2c096bb-cfed-bfa4-e053-2995a90af2cb.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-71621130-716-08, 21130-716-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYDEXTROSEVH2XOU12IEIACT
POVIDONEFZ989GH94EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
FERRIC OXIDE RED1K09F3G675IACT
ACETAMINOPHEN362O9ITL9DACTIB
IBUPROFENWK2XYI10QMACTIB

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 1.

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
A216994-001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORAL2023-07-10

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
2026-02-19 14:30 UTC2026-02A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-108072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-10a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216994-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2023-07-10a50c72e98297…

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 ActionACETAMINOPHEN, IBUPROFENBETTER LIVING BRANDS, LLCf2c096bb-cfed-bfa4-e053-2995a90af2cb2024-08-22WarningsExact identifier
ndc (package): 21130-716-75
ndc (package): 21130-716-08
ndc (product): 21130-716
ndc11 (package): 21130071608
ndc11 (package): 21130071675
spl id: 20402a78-3dea-b88c-e063-6294a90ab75a
spl set id: f2c096bb-cfed-bfa4-e053-2995a90af2cb