Ibuprofen Tablets Usp, 200 Mg

Ibuprofen Tablets Usp, 200 Mg
SPL v6
SPL
SPL Set ID 10424ad8-74fc-4f5f-e063-6394a90a13bd
Route
ORAL
Published
Effective Date 2024-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G;2 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2024-05-25

Description

Ibuprofen 200 mg (NSAID)*

Purpose

Pain reliever/ fever reducer


Medication Information

Purpose

Pain reliever/ fever reducer

Description

Ibuprofen 200 mg (NSAID)*

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

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 n skin reddening
  • rash n blisters

If an allergic reaction occurs, stop use and seek medical help right away.

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, unlessdirected by a doctor.
  • children under 12 • 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
Other Information
  • store between 20 – 25°C (68 – 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 to 5:00 PM PST

Principal Diaplay 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 chances is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning(anticoagulant) or steroiddrug
  • 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 n 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 n 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 Tablet)

Ibuprofen 200 mg (NSAID)*

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

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 n skin reddening
  • rash n blisters

If an allergic reaction occurs, stop use and seek medical help right away.

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, unlessdirected by a doctor.
  • children under 12 • 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
Other Information
  • store between 20 – 25°C (68 – 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 to 5:00 PM PST

Principal Diaplay Panel (Principal diaplay 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 chances is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning(anticoagulant) or steroiddrug
  • 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 n 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 n 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 Tablet) (Active ingredient (in each tablet))

Ibuprofen 200 mg (NSAID)*

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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