467 - Ibuprofen 200mg Tablet

467 - Ibuprofen 200mg Tablet
SPL v2
SPL
SPL Set ID 265e2b47-d14a-45a8-adc0-7214e2057103
Route
ORAL
Published
Effective Date 2024-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Fd&c Blue No. 2 Fd&c Yellow No. 5 Fd&c Yellow No. 6 Ferric Oxide Red Lecithin, Soybean Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: BI06 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2024-10-10

Description

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

Purpose

Pain Reliever/Fever reducer


Medication Information

Purpose

Pain Reliever/Fever reducer

Description

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

Use(s)

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 chances are 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. Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

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
Other Information
  • store between 20-25 °C (68-77° F) 
  • read all warnings and directions before use
  • do not use if seal under bottle cap is broken or missing
Questions/comments

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST

Active Ingredient(s)

Ibuprofen USP, 200mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C

Blue #2, FD&C Yellow #5, FD&C Yellow #6, Iron Oxide Red, Lecithin, Magnesium

Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol,

Pregelatinized Starch, Talc, Titanium Dioxide.

Principal Display Panel
Ibuprofen
When Using This Product
  • take with food or milk if stomach upset occurs
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, 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
If Pregnant Or Breastfeeding,

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

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

Ask A Doctor Or Pharmacist Before Use If
  • 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

Use(s)

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 chances are 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. Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

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
Other Information (Other information)
  • store between 20-25 °C (68-77° F) 
  • read all warnings and directions before use
  • do not use if seal under bottle cap is broken or missing
Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST

Active Ingredient(s) (Active ingredient(s))

Ibuprofen USP, 200mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C

Blue #2, FD&C Yellow #5, FD&C Yellow #6, Iron Oxide Red, Lecithin, Magnesium

Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol,

Pregelatinized Starch, Talc, Titanium Dioxide.

Principal Display Panel
Ibuprofen
When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
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, 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
If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

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.

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • 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

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