Ibuprofen Tablets Usp, 200 Mg

Ibuprofen Tablets Usp, 200 Mg
SPL v3
SPL
SPL Set ID ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b
Route
ORAL
Published
Effective Date 2023-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Magnesium Stearate Cellulose, Microcrystalline Starch, Corn Sodium Starch Glycolate Type A Potato Hypromellose, Unspecified Titanium Dioxide Triacetin Fd&c Yellow No. 6 Talc

Identifiers & Packaging

Pill Appearance
Imprint: IBU200 Shape: round Shape: capsule Color: white Color: orange Size: 10 mm Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2022-03-18

Description

Important: Read all product information before using. Keep the box for important information.


Medication Information

Recent Major Changes

Important: Read all product information before using.

Keep the box for important information.

Description

Important: Read all product information before using. Keep the box for important information.

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
Section 42229-5

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
Section 44425-7

Other Information

  • store between 20-250C (68-770F)
  • do not use if carton is opened. Do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing
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

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
Section 50567-7

When using this product

  • take with food or milk if stomach upset occurs
Section 50568-5

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
Section 53414-9

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.

Section 55105-1

Purpose

Pain reliever / fever reducer

Section 55106-9

Active ingredient (in each Orange caplet **)

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

**capsule-shaped tablets

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 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       

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.

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       
Inactive Ingredients

colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide, and triacetin

Questions Or Comments

Call 1-877-244-9825 (toll-free)

Package Label.principal Display Panel

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
Recent Major Changes (34066-1)

Important: Read all product information before using.

Keep the box for important information.

Section 42229-5 (42229-5)

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
Section 44425-7 (44425-7)

Other Information

  • store between 20-250C (68-770F)
  • do not use if carton is opened. Do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing
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)

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
Section 50567-7 (50567-7)

When using this product

  • take with food or milk if stomach upset occurs
Section 50568-5 (50568-5)

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
Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose

Pain reliever / fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each Orange caplet **)

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

**capsule-shaped tablets

Warnings (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 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       

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.

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       
Inactive Ingredients

colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide, and triacetin

Questions Or Comments (Questions or Comments)

Call 1-877-244-9825 (toll-free)

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data


Raw Label Data

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