Acetaminophen Ibuprofen (NSAID)

Manufacturer
Dr. Reddy's Labortories Inc | Dr. Reddy's Laboratories Limited-FTO-3
Effective date
2025-02-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:55:46

Label at a glance#

ProductAcetaminophen Ibuprofen (NSAID)
Active ingredientIBUPROFEN, ACETAMINOPHEN
Label structure13 sections

Indications and uses

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

Storage and handling

Other information • 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#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

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

Uses

INDICATIONS & USAGE SECTION

Uses

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

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 (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 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 SECTION

Other information

  • 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 INGREDIENT SECTION

Inactive ingredients

black iron oxide, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, glyceryl dibehenate, hypromellose, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, sodium lauryl sulfate, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?

call 1-888-375-3784 Weekdays (8 AM to 8 PM EST)

Distributed By:

Dr. Reddy's Laboratories, Inc.

Princeton, NJ 08540

Made in India

Rev: 02/25


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PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

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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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-260-14Acetaminophen Ibuprofen (NSAID)144 in 1 BOTTLETABLET, FILM COATED1441
75907-260-18Acetaminophen Ibuprofen (NSAID)18 in 1 BOTTLETABLET, FILM COATED181
75907-260-18Acetaminophen Ibuprofen (NSAID)1 in 1 CARTONTABLET, FILM COATED11
75907-260-25Acetaminophen Ibuprofen (NSAID)250 in 1 BOTTLETABLET, FILM COATED2501
75907-260-25Acetaminophen Ibuprofen (NSAID)1 in 1 CARTONTABLET, FILM COATED11
75907-260-55Acetaminophen Ibuprofen (NSAID)500 in 1 BOTTLETABLET, FILM COATED5001
75907-260-95Acetaminophen Ibuprofen (NSAID)250 in 1 BOTTLETABLET, FILM COATED2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-260ACETAMINOPHEN IBUPROFEN (NSAID) (ACETAMINOPHEN AND IBUPROFEN) TABLET, FILM COATED [DR. REDDY'S LABORTORIES INC]17 package rows20250223_ff2711de-dbd1-9957-86c6-8222eba8b712.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
75907-26075907-260-18, 75907-260-25, 75907-260-55, 75907-260-14, 75907-260-95

Ingredients#

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

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

Source Document#

Source XML

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
7c1b1f21-5342-b733-2043-89c290a24bdeff2711de-dbd1-9957-86c6-8222eba8b7122025-02-06WarningsExact identifier
spl id: 7c1b1f21-5342-b733-2043-89c290a24bde
spl set id: ff2711de-dbd1-9957-86c6-8222eba8b712

Reported adverse events (FAERS/openFDA)#

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