Drug label · Pain & musculoskeletal

Ibuprofen drug label

openFDA · Retrieved 2026-10-13

Ibuprofen label record for ibuprofen. The label lists Lidl US LLC as labeler/manufacturer. Route: oral. Includes selected complete prescribing-information sections from openFDA; consult the linked original label for the complete document.

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Reference details

Brand name
Ibuprofen
Generic name
IBUPROFEN
Active substance
IBUPROFEN
Labeler / manufacturer listed
Lidl US LLC
Route
ORAL
Product type
HUMAN OTC DRUG
Pharmacologic class
Nonsteroidal Anti-inflammatory Drug [EPC]
Application number
ANDA079174
Label version
5
SPL set ID
0ca02f8b-4413-4e7c-a67b-8c67c53e1343
Label effective date
2026-09-09
openFDA dataset updated
2026-10-13

Indications and usage

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

Purpose

Purposes Pain reliever/fever reducer

Warnings

Warnings 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 if you have ever had an allergic reaction to ibuprofen any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers the 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 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 When using this product take with food or milk if stomach upset occurs 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 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 ■ 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, 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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Do not use

Do not use if you have ever had an allergic reaction to ibuprofen any other pain reliever/fever reducer right before or after heart surgery

Ask doctor

Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers the 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

Ask doctor or pharmacist

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

When using

When using this product take with food or milk if stomach upset occurs

Stop use

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 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 ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present in the painful area ■ any new symptoms appear

Dosage and administration

Directions ■ do not take more than directed ■ the smallest effective dose should be used ■ adults and children 12 years and older: ■ 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

Pregnancy or breast feeding

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.

Keep out of reach of children

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)

Active ingredient

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

Inactive ingredient

Inactive ingredients colloidal silicon dioxide, corn starch, iron oxide red, polyethylene glycol, polyvinyl alcohol, povidone K30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

Storage and handling

Other information read all warnings and directions before use store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

Sources and reuse

Selected source label sections. Check the original for the complete label, formatting and latest version.
Selected complete plain-text label sections. Tables and images may require consulting the linked original label. This is a reference copy, not prescribing advice.
Source date: 2026-09-09. Retrieved: 2026-10-13. Text has been organized for reading; this import has not been independently reviewed by a clinician. It is not individualized medical advice.

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