Ibuprofen Tablets Usp 200 Mg
119263b5-c3b7-46dc-a3bd-9893bfd24628
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
Drug Facts
Uses
- temporarily relieves minor aches and pain due to:
- headache
- toothache
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
- temporarily reduces fever
Section 42229-5
Drug Facts (continued)
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
¬ chest pain ¬ trouble breathing
¬ leg swelling ¬ slurred speech
¬ weakness in one part or side of body
¬ 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
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.
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 a
nonsteroidal anti-inflammatory drug (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
Directions
¬ do not take more than directed
¬ the smallest effective dose should be used
¬ do not take longer than 10 days, unless directed by a
doctor (see Warnings)
¬ adults and children 12 years and over: 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 to any other pain reliever/fever reducer
- right before or after heart surgery
Drug Facts
Drug Facts
Active Ingredient
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Other Information
¬ read all warnings and directions before use.
¬ store between 20°-25°C (68°-77°F)
¬ avoid excessive heat above 40°C (104°F)
Inactive Ingredients
colloidal silicon
dioxide, FD&C yellow no. 6, maize starch, polyethylene
glycol, polyvinyl alcohol, povidone k30,
pregelatinized starch, sodium starch glycolate, stearic
acid, talc, titanium dioxide.
Questions Or Comments?
1-888-333-9792
Principal Display Panel
Ibuprofen
Ibuprofen Tablets 200 mg -
Pain reliever/fever reducer (NSAID)
When Using This Product
¬ take with food or milk if stomach upset occurs
¬ the risk of heart attack or stroke may increase if you
use more than directed or for longer than directed
Ask A Doctor Before Use If
¬ the 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
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:
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
Structured Label Content
Uses
- temporarily relieves minor aches and pain due to:
- headache
- toothache
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
- temporarily reduces fever
Section 42229-5 (42229-5)
Drug Facts (continued)
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)
¬ chest pain ¬ trouble breathing
¬ leg swelling ¬ slurred speech
¬ weakness in one part or side of body
¬ 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
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.
Purpose
Pain reliever/fever reducer
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 a
nonsteroidal anti-inflammatory drug (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
Directions
¬ do not take more than directed
¬ the smallest effective dose should be used
¬ do not take longer than 10 days, unless directed by a
doctor (see Warnings)
¬ adults and children 12 years and over: 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 to any other pain reliever/fever reducer
- right before or after heart surgery
Drug Facts
Drug Facts
Active Ingredient (Active ingredient)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Other Information (Other information)
¬ read all warnings and directions before use.
¬ store between 20°-25°C (68°-77°F)
¬ avoid excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)
colloidal silicon
dioxide, FD&C yellow no. 6, maize starch, polyethylene
glycol, polyvinyl alcohol, povidone k30,
pregelatinized starch, sodium starch glycolate, stearic
acid, talc, titanium dioxide.
Questions Or Comments? (Questions or comments?)
1-888-333-9792
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Ibuprofen
Ibuprofen Tablets 200 mg -
Pain reliever/fever reducer (NSAID)
When Using This Product (When using this product)
¬ take with food or milk if stomach upset occurs
¬ the risk of heart attack or stroke may increase if you
use more than directed or for longer than directed
Ask A Doctor Before Use If (Ask a doctor before use if)
¬ the 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
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:
Ask A Doctor Or Pharmacist Before Use If You Are (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
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Source: dailymed · Ingested: 2026-02-15T12:04:43.693518 · Updated: 2026-03-14T23:05:37.016425