IBUPROFEN

Manufacturer
HART Health
Effective date
2024-01-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:55

Label at a glance#

ProductIBUPROFEN
Active ingredientIBUPROFEN
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet): Ibuprofen (NSAID*) 200mg (*nonsteroidal anti-inflammatory drug)

OTC - PURPOSE SECTION

Purpose: Pain Reliever / Fever Reducer

INDICATIONS & USAGE SECTION

Uses: Temporarily relieves minor aches and pains due to

  • headache
  • muscular aches
  • backache
  • minor arthritis pain
  • the common pain
  • toothache
  • menstrual cramps

Temporarily reduces fever

WARNINGS SECTION

Warnings:

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • rash
  • shock
  • facial swelling
  • asthma (wheezing)
  • skin reddening
  • blisters

Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or non-prescriptin NSAIDs (aspirin, ibuprofen, naproxen, or others)

OTC - DO NOT USE SECTION

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you

  • take any other drug containing an NSAID
  • take a blood thinning (anticoagulant) or steroid drug
  • take aspirin for heart attach or stroke (ibuprofen may decrease the benefit if aspirin)
  • are under a doctor's care for any serious condition

OTC - WHEN USING SECTION

When using this product

  • take with food or milk if stomach upset occurs
  • long term continuous use may increase the risk of heart attack or stroke

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • an allergic reaction occurs, seek medical help right away
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area
  • new symptoms occur
  • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better

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 during the last 3 months of 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

DOSAGE & ADMINISTRATION SECTION

Directions:

Do not take more than directed; the smallest effective dose should be used.

Adults and children 12 years of age and over:

  • take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tabet, 2 tablets may be used
  • do not take more than 6 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch*, Croscarmellose Sodium*, Hypromellose*, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol*, Polyvinyl Alcohol*, Pregelantinized Starch, Red Iron Oxide, Sodium Starch Glycolate*, Talc, Titanium Dioxide, Triacetin*.

*Contains one or more of these ingredients.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN3
310965ibuprofen 200 MG Oral TabletSCD3
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY3

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0152IBUPROFEN TABLET [HART HEALTH]3Current NDC20240126_1c1374e1-890f-48ab-8f93-e84da9d5bf84.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-015250332-0152-4, 50332-0152-7, 50332-0152-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
IBUPROFENIBUPROFENHART Health1c1374e1-890f-48ab-8f93-e84da9d5bf842024-01-25WarningsExact identifier
ndc (package): 50332-0152-4
ndc (package): 50332-0152-8
ndc (package): 50332-0152-7
ndc (product): 50332-0152
ndc11 (package): 50332015208
ndc11 (package): 50332015207
ndc11 (package): 50332015204
spl id: 24531295-6ee5-4fcb-857b-50c3ea59e3c3
spl set id: 1c1374e1-890f-48ab-8f93-e84da9d5bf84

Reported adverse events (FAERS/openFDA)#

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