Ibuprofen Tablets Usp, 200 Mg
1a00c17f-9766-deaa-e063-6394a90a8d60
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/ fever reducer
Medication Information
Purpose
Pain reliever/ fever reducer
Description
Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
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
Purposes
Pain reliever/ fever reducer
Directions
do not take more than directed
the smallest effective dose should be used
adults and children 12 years and older
take 1 caplet every 4 to 6 hours while symptoms persist
if pain or fever does not respond to 1 caplet, 2 caplets may be used
do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years
ask a doctor
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
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.
Other Information
store between 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]
avoid excessive heat above 40°C (104°F)
Inactive Ingredients
colloidal silicon dioxide, iron oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions Or Comments?
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Principal Display Panel
When Using This Product
take with food or milk if stomach upset occurs
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
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
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)
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.
Active Ingredient (in Each Caplet)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
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
Structured Label Content
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
Purposes
Pain reliever/ fever reducer
Directions
do not take more than directed
the smallest effective dose should be used
adults and children 12 years and older
take 1 caplet every 4 to 6 hours while symptoms persist
if pain or fever does not respond to 1 caplet, 2 caplets may be used
do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years
ask a doctor
Do Not Use (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
Allergy Alert: (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.
Other Information (Other information)
store between 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]
avoid excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)
colloidal silicon dioxide, iron oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions Or Comments? (Questions or comments?)
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Principal Display Panel
When Using This Product (When using this product)
take with food or milk if stomach upset occurs
Stomach Bleeding Warning: (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
Ask A Doctor Before Use If (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
Stop Use and Ask A Doctor If (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 (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)
Heart Attack and Stroke Warning: (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.
Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Ask A Doctor Or Pharmacist Before Use If You Are (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
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Source: dailymed · Ingested: 2026-02-15T12:07:49.043002 · Updated: 2026-03-14T23:11:40.308391