Kroger Ibuprofen Tablets 200 mg (Brown Round)

Manufacturer
Kroger Company | Time Cap Laboratories, Inc. | MARKSANS PHARMA LIMITED
Effective date
2025-09-24
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:14:45

Label at a glance#

ProductIBUPROFEN
Active ingredientIBUPROFEN
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purpose
Pain reliever/Fever reducer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
•asthma (wheezing)
•blisters
•facial swelling
•hives
•rash
•shock
•skin reddening.
If an allergic reaction occurs, stop use and seek medical help right away.
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
•if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
•right before or after heart surgery

OTC - ASK DOCTOR SECTION

Ask a doctor before use if
•you have problems or serious side effects from taking pain relievers or fever reducers
•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, 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
•taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
•under a doctor’s care for any serious condition
•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 problem or stroke:
chest pain
trouble breathing
weakness in one part or side of the body
slurred speech
leg swelling
•pain gets worse or lasts more than 10 days
•fever gets worse or lasts more than 3 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).

DOSAGE & ADMINISTRATION SECTION

Directions
•do not take more than directed
•the smallest effective dose should be used

adults and children 12 years and over:
•take 1 tablet every 4 to 6 hours while symptoms persist
•if pain or fever does not respond to 1 tablet, 2 tablets may be used
•do not exceed 6 tablets in 24 hours, unless directed by a doctor

children under 12 years:
•ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Other information

  • read all warnings and directions before use
  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc,titanium dioxide.

OTC - QUESTIONS SECTION

Questions or comments? 1-800-632-6900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

500s-label-ibu500s-label-ibu250s-tabs-label250s-tabs-label200s-tabs-label200s-tabs-label100s-tabs-label100s-tabs-label100s-tabs-ifc100s-tabs-ifc24s-tabs-label24s-tabs-label24s-tabs-ifc24s-tabs-ifcibu-500s-label-comboibu-500s-label-combo

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN6
310965ibuprofen 200 MG Oral TabletSCD6
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY6

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
41226-601-01IBUPROFEN1 in 1 CARTONTABLET, COATED16
41226-601-01IBUPROFEN100 in 1 BOTTLETABLET, COATED1006
41226-601-05IBUPROFEN1 in 1 CARTONTABLET, COATED16
41226-601-05IBUPROFEN50 in 1 BOTTLETABLET, COATED506
41226-601-10IBUPROFEN2 in 1 PACKAGE, COMBINATIONTABLET, COATED26
41226-601-20IBUPROFEN200 in 1 BOTTLETABLET, COATED2006
41226-601-25IBUPROFEN250 in 1 BOTTLETABLET, COATED2506
41226-601-42IBUPROFEN24 in 1 BOTTLETABLET, COATED246
41226-601-42IBUPROFEN1 in 1 CARTONTABLET, COATED16
41226-601-53IBUPROFEN500 in 1 BOTTLETABLET, COATED5006

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41226-60141226-601-42, 41226-601-05, 41226-601-01, 41226-601-20, 41226-601-25, 41226-601-53, 41226-601-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
IBUPROFENIBUPROFENKroger Companybbedfc37-913d-8046-e053-2995a90af68a2025-09-24WarningsExact identifier
ndc (package): 41226-601-25
ndc (package): 41226-601-20
ndc (package): 41226-601-10
ndc (package): 41226-601-53
ndc (package): 41226-601-42
ndc (package): 41226-601-01
ndc (package): 41226-601-05
ndc (product): 41226-601
ndc11 (package): 41226060110
ndc11 (package): 41226060142
ndc11 (package): 41226060125
ndc11 (package): 41226060120
ndc11 (package): 41226060153
ndc11 (package): 41226060101
ndc11 (package): 41226060105
spl id: 3f89772f-94d8-4e14-e063-6294a90a769b
spl set id: bbedfc37-913d-8046-e053-2995a90af68a

Reported adverse events (FAERS/openFDA)#

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