Drug Facts
17331594-e332-4ada-9b6b-3805d92f0e98
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Ibuprofen USP, 200mg (NSAID)** **nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
Ibuprofen USP, 200mg (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
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
Do Not Use
if you have ever had an allergic reaction to 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.
Active Ingredient
Ibuprofen USP, 200mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Other Information
store between 20-25 °C (68-77° F). ■ Read all warnings and directions before use Do not use if
seal under bottle cap is broken or missing.
Inactive Ingredients
Colloidal silicon dioxide, corn starch, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin
Questions Or Comments?
Call 1-888-952-0050
Monday through Friday 9AM – 5PM EST
When Using This Product
take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stomach Bleeding Warning
This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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, or kidney disease ■ you have asthma ■ 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 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 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
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).
Package/label Principal Display Panel
Ask A Doctor Or Pharmacist Before Use If You Are
■ taking aspirin to prevent 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
Purpose
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 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
Do Not Use (Do not use)
if you have ever had an allergic reaction to 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.
Active Ingredient (Active ingredient)
Ibuprofen USP, 200mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Other Information (Other information)
store between 20-25 °C (68-77° F). ■ Read all warnings and directions before use Do not use if
seal under bottle cap is broken or missing.
Inactive Ingredients
Colloidal silicon dioxide, corn starch, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin
Questions Or Comments? (Questions or Comments?)
Call 1-888-952-0050
Monday through Friday 9AM – 5PM EST
When Using This Product (When using this product)
take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stomach Bleeding Warning (Stomach bleeding warning)
This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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, or kidney disease ■ you have asthma ■ 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 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 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
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).
Package/label Principal Display Panel (Package/Label Principal Display Panel)
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
■ taking aspirin to prevent 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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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:55:52.985766 · Updated: 2026-03-14T22:53:55.198203