Drug Facts
16b751a9-2f33-4303-b75f-ca0c012a212d
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
Dosage and Administration
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and over: 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
Description
Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug
Uses
- 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
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.
Do Not Use
- if you have ever had an allergic reaction to any other pain reliever/fever reducer
- right before or after heart surgery
Other Information
- each tablet contains: sodium 22 mg
- read all warnings and directions before use
- Keep carton or card
- store at 20 - 25°C (68 - 77°F)
- avoid excessive heat above 40°C (104°F)
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, magnesium stearate,microcrystalline cellulose, talc, titanium dioxide
Questions Or Comments
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
Principal Display Panel
NDC 70005-009-25
SEE NEW WARNINGS AND DIRECTIONS
We Care
For Good Health
COMPARE TO ACTIVE INGREDIENT IN Advil®* CAPLETS
TO OPEN PUSH IN TAB AND PULL OUT
Ibuprofen 200 mg
Pain Reliever/Fever Reducer (NSAID)
- Headache
- Toothache
- Minor Pain of Arthritis
- Fever
- Muscularache
- Menstrual Cramps
Ibuprofen
*This product is not manufactured or distributed by Pfizer Healthcare, owner of the registered trademark of Advil®* tablets.
25 Pouches of 2 Coated Tablets
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
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
- 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, or 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
Keep Out of Reach of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Active Ingredient(in Each Tablet)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
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 pains due to:
- headache
- toothache
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
- temporarily reduces fever
Dosage and Administration (34068-7)
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and over: 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
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.
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
Other Information (Other information)
- each tablet contains: sodium 22 mg
- read all warnings and directions before use
- Keep carton or card
- store at 20 - 25°C (68 - 77°F)
- avoid excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)
colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, magnesium stearate,microcrystalline cellulose, talc, titanium dioxide
Questions Or Comments (Questions or Comments)
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
Principal Display Panel
NDC 70005-009-25
SEE NEW WARNINGS AND DIRECTIONS
We Care
For Good Health
COMPARE TO ACTIVE INGREDIENT IN Advil®* CAPLETS
TO OPEN PUSH IN TAB AND PULL OUT
Ibuprofen 200 mg
Pain Reliever/Fever Reducer (NSAID)
- Headache
- Toothache
- Minor Pain of Arthritis
- Fever
- Muscularache
- Menstrual Cramps
Ibuprofen
*This product is not manufactured or distributed by Pfizer Healthcare, owner of the registered trademark of Advil®* tablets.
25 Pouches of 2 Coated Tablets
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
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)
- 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, or 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
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.
Active Ingredient(in Each Tablet) (Active ingredient(in each tablet))
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)
- 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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:56:02.344023 · Updated: 2026-03-14T22:54:12.692887