FDA.reportPublic FDA data

Quality Plus 44-798 ANDA

Manufacturer
L.N.K. International, Inc. | LNK International, Inc.
Effective date
2026-09-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-09-15 03:02:14

Label at a glance#

ProductAcetaminophen and Ibuprofen
Active ingredientACETAMINOPHEN, IBUPROFEN
Label structure9 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. store between 20°-25°C (68°-77°F) avoid excessive heat above 40°C (104°F) use by expiration date on package

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
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. 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.
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
  • use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, corn starch, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone K30, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY
+PLUS

NDC 50844-598-14

†Compare to active ingredients in
Advil® Dual Action with Acetaminophen

8 HOUR
RELIEF

ACETAMINOPHEN and
IBUPROFEN (NSAID)
TABLETS 250 mg/125 mg

PAIN RELIEVER

500 Caplets**
**CAPSULE-SHAPED TABLETS

ACTUAL
SIZE

CONTAINS 2 MEDICINES
Acetaminophen + Ibuprofen

Quality Plus 44-798
Quality Plus 44-798

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130350844598141GTIN-13: 0350844598141
EAN-13: 0350844598141
GTIN-12: 350844598141
UPC-A: 350844598141
GTIN storage (14 digits): 00350844598141		quality-plus-44-798-anda-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50844-59850844-598-19, 50844-598-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
IBUPROFENWK2XYI10QMACTIB
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CROSPOVIDONE, UNSPECIFIED2S7830E561IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE K30U725QWY32XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
A220126-001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORAL2025-12-11

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 22:38:342026-08A220126-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2025-12-1184e616aacf4f…
2026-08-18 06:07:402026-07A220126-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2025-12-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220126-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2025-12-11011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220126-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2025-12-11a50c72e98297…

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
0ac0aabc-5fb9-4ae1-8c1f-7e023a930b75339a32d8-e407-4c8d-8c19-8858d0e3959e2026-09-10WarningsExact identifier
spl set id: 339a32d8-e407-4c8d-8c19-8858d0e3959e

Reported adverse events (FAERS/openFDA)#

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