FDA.reportPublic FDA data

Ibuprofen

Manufacturer
The Kroger Co.
Effective date
2023-08-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:22:53

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

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

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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 problem 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
  • fever gets worse or lasts more than 3 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 during the last 3 month of 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over:
    • take 1 capsule every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 capsule, 2 capsules may be used
    • do not exceed 6 capsules in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use.
  • store at 20° to 25°C (68° to 77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitol

Questions & Comments

OTC - QUESTIONS SECTION

Call 1-800-632-6900

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient of Advil® Liquid-Gels®

Ibuprofen

Capsules, 200 mg

Pain Reliever/Fever Reducer (NSAID)

Softgels**

(**Liquid-filled capsules)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® Liqui-Gels®.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KROGER Ibuprofen Capsules 200 mg
KROGER Ibuprofen Capsules 200 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-728IBUPROFEN CAPSULE, LIQUID FILLED [THE KROGER CO.]1Unmatched20231031_2e9070e9-ae3a-4697-8eae-d797cf8c850f.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-72830142-728-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
IBUPROFENWK2XYI10QMACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

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
f3281665-c754-43e5-9aca-84d29ee0d4712e9070e9-ae3a-4697-8eae-d797cf8c850f2026-01-06WarningsExact identifier
spl set id: 2e9070e9-ae3a-4697-8eae-d797cf8c850f

Reported adverse events (FAERS/openFDA)#

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