Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID dd63b011-0573-4374-9669-8d29146e5fc9
Route
ORAL
Published
Effective Date 2017-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Starch, Corn Hypromelloses Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Sodium Starch Glycolate Type A Corn Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: IBU200 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2014-12-19

Description

Ibuprofen USP, 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Ibuprofen USP, 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
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 

  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.

Directions
  • 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
Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Inactive Ingredients

corn starch, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc, titanium dioxide, triacetin

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

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 youyou 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

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Package/label Principal Display Panel

HealthA2Z®

Compare to Advil® active ingredient**

FAST RELIEF MEDICINE FOR PAIN

Ibuprofen

(NSAID)*

SEE NEW WARNINGS

Ibuprofen Tablets 200mg

Pain Reliever/Fever Reducer

(pill image)

Tablets

Ibuprofen 200mg
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
  • toothache 
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
  • temporarily reduces fever
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 

  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.

Directions
  • 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
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
Inactive Ingredients

corn starch, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc, titanium dioxide, triacetin

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

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 youyou 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

If Pregnant Or Breast Feeding, (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. (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 (1-800-222-1222) right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Package/label Principal Display Panel (Package/Label Principal Display Panel)

HealthA2Z®

Compare to Advil® active ingredient**

FAST RELIEF MEDICINE FOR PAIN

Ibuprofen

(NSAID)*

SEE NEW WARNINGS

Ibuprofen Tablets 200mg

Pain Reliever/Fever Reducer

(pill image)

Tablets

Ibuprofen 200mg
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


Advanced Ingredient Data


Raw Label Data

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