Ibuprofen
1c1374e1-890f-48ab-8f93-e84da9d5bf84
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active Ingredient (in each tablet): Ibuprofen (NSAID*) 200mg (*nonsteroidal anti-inflammatory drug)
Medication Information
Warnings and Precautions
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)
Indications and Usage
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
Dosage and Administration
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
Description
Active Ingredient (in each tablet): Ibuprofen (NSAID*) 200mg (*nonsteroidal anti-inflammatory drug)
Section 50565-1
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
Section 50566-9
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
Section 50567-7
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
Section 50568-5
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
Section 50569-3
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
Section 50570-1
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Section 51727-6
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.
Section 51945-4
Section 53414-9
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
Section 55105-1
Purpose: Pain Reliever / Fever Reducer
Section 55106-9
Active Ingredient (in each tablet): Ibuprofen (NSAID*) 200mg (*nonsteroidal anti-inflammatory drug)
Structured Label Content
Indications and Usage (34067-9)
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
Dosage and Administration (34068-7)
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
Warnings and Precautions (34071-1)
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)
Section 50565-1 (50565-1)
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
Section 50566-9 (50566-9)
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
Section 50567-7 (50567-7)
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
Section 50568-5 (50568-5)
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
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
Do not use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Section 51727-6 (51727-6)
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.
Section 51945-4 (51945-4)
Section 53414-9 (53414-9)
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
Section 55105-1 (55105-1)
Purpose: Pain Reliever / Fever Reducer
Section 55106-9 (55106-9)
Active Ingredient (in each tablet): Ibuprofen (NSAID*) 200mg (*nonsteroidal anti-inflammatory drug)
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Source: dailymed · Ingested: 2026-02-15T12:02:44.555735 · Updated: 2026-03-14T23:02:26.872598