Ibuprofen is an over-the-counter medicine (Nonsteroidal Anti-inflammatory Drug). The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Over the counter (OTC)
- Brand names
- Motrin IB, Childrens Motrin, Advil, Junior Strength Advil, Childrens Advil, Dolex Flex, Dover Addaprin
- Drug class
- Nonsteroidal Anti-inflammatory Drug
- Taken
- Oral
- Label
- Haleon US Holdings LLC, revised July 29, 2026 · full label on DailyMed
Purpose
Pain reliever/Fever reducer
What it is used for
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
Active ingredient
Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug
Do not use
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 you have
if 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
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
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
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 any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if 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 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 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.
Pregnancy or breastfeeding
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.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Ibuprofen in the news
We have not covered this medicine yet. Latest news
Recalls
-
Class II Ongoing
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
Reason: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Lots, distribution and details
- Lots / codes
- Lot: 7261973A, 7261974A, Exp 01/31/2027
- Distribution
- U.S.A. Nationwide
- Quantity
- 89592 bottles
- Recall started
- March 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0390-2026
-
Class III Ongoing
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
Reason: Failed Tablet/Capsule Specifications
Lots, distribution and details
- Product
- IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
- Lots / codes
- Lot #: C5406201, Exp 03/31/2028
- Distribution
- USA Nationwide
- Quantity
- 3416 botttles
- Recall started
- October 29, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0047-2025
-
Class II Ongoing
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 619…
Reason: Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Lots, distribution and details
- Product
- Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).
- Lots / codes
- Lot #s: a) 02FE2414, Exp 11/30/26. b) 18JU2407, Exp 11/30/26; 27JY2316, Exp 02/28/27; 13SE2317, 13OC2312, 23AU2307, Exp 03/31/27. c) 25SE2308, Exp 03/31/27. d) 29MA2313, 23MA2315, Exp 12/31/26; 25MY2304, Exp 01/31/27; 26JU2313, 27JY2314, Exp 02/28/27. e) 27SE2322, 30OC2304, 12OC2301, Exp 03/31/27. f) 11SE2322, 02FE2419, 23JA2405, 10JA2426, 17MY2416, 05DE2312, 24OC2321, 05FE2433, 20MA2418, 29NO2317, Exp 11/30/26. g) 31MA2308, Exp 12/31/26; 25SE2305, Exp 03/31/27.
- Distribution
- Nationwide in the US
- Quantity
- 1410 bottles
- Recall started
- August 9, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0041-2025
-
Class II Ongoing
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
Reason: Failed Impurities/Degradation Specifications – at 18-month Stability testing
Lots, distribution and details
- Lots / codes
- Lot: B0223H, Exp: 5/31/2026; C3023H, Exp: 9/30/2026.
- Distribution
- CA and NV
- Quantity
- 266 bottles
- Recall started
- August 8, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0647-2024
-
Class II Ongoing
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 – 100 Tablets per bottle, b) NDC 55111-682-05 – 500 Tablets per bottle.
Reason: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots, distribution and details
- Lots / codes
- a)NDC 55111-682-01 Lots C2207529, Exp 5/31/2026; C2210993, Exp 9/30/2026. b)NDC 55111-682-05 Lots C2207530, Exp 5/31/2026; C2210992, C2210994, Exp 9/30/2026; C2213304, C2213305, Exp 11/30/2026.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 14940 bottles
- Recall started
- August 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0646-2024
-
Class II Ongoing
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 – 100 Tablets per bottle, b)NDC 5511-683-05 – 500 Tablets per bottle.
Reason: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots, distribution and details
- Lots / codes
- a)NDC 55111-683-01 Lots C2207527, Exp 5/31/2026; C2210864, Exp 9/30/2026; C2213018, Exp 11/30/2026. b)NDC 5511-683-05 Lots C2207528, Exp 5/31/2026; C2210860, Exp 9/30/2026; C2213016, C2213017, Exp 11/30/2026; C2301852, C2302056, C2302057, Exp 1/31/2027.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 31,802 bottles
- Recall started
- August 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0645-2024
-
Class II Ongoing
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 – 100 Tablets per bottle, b)NDC 55111-684-05 – 500 Tablets per bottle.
Reason: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots, distribution and details
- Product
- IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 – 100 Tablets per bottle, b)NDC 55111-684-05 – 500 Tablets per bottle.
- Lots / codes
- a) NDC 55111-684-01 Lots C2207525, Exp 5/31/2026; C2212902, Exp 11/30/2026. b) NDC 55111-684-05 Lots C2207526, Exp 5/31/2026; C2210751, C2210752, Exp 9/30/2026; C2212765, C2212766, Exp 11/30/2026; C2301027, C2301063, C2301187, C2301188, C2301247, Exp 12/31/2026; C2301356, C2301388, C2301494, C2301478, C2301617, Exp 1/31/2027; C2303381, C2303432, C2303565, C2303630, C2303643, C2303710, Exp 2/28/2027; C2303879, C2303806, C2303895, C2303963, C2304263, C2304264, C2304130, C2304163, C2304427, Exp 3/31/2027.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 103,298 bottles
- Recall started
- August 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0644-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Ibuprofen
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 1f01c10a-9434-91a4-2ee4-352315a6b610.