Ibuprofen Tablets Usp, 200 Mg

Ibuprofen Tablets Usp, 200 Mg
SPL v5
SPL
SPL Set ID 1a00c17f-9766-deaa-e063-6394a90a8d60
Route
ORAL
Published
Effective Date 2024-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Starch, Corn Povidone K30 Polyethylene Glycol 4000 Stearic Acid Ferric Oxide Red Silicon Dioxide Sodium Starch Glycolate Type A Potato Titanium Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: G;2 Shape: oval Color: red Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2024-10-17

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


Advanced Ingredient Data


Raw Label Data

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