466 - Ibuprofen 200mg Caplet

466 - Ibuprofen 200mg Caplet
SPL v2
SPL
SPL Set ID 2ea039d6-f522-4103-a1f9-5b80a3b12a27
Route
ORAL
Published
Effective Date 2025-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Fd&c Blue No. 2 Fd&c Yellow No. 6 Lecithin, Soybean Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: BI;03 Shape: capsule Color: orange Size: 15 mm Score: 1
Marketing Status
ANDA Active Since 2025-04-16

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 n 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 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. 

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
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-Friday 9 AM – 5 PM EST)

Active Ingredient(s)

Ibuprofen USP, 200mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow #10, FD&C Blue #2, FD&C Yellow #6,

Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized

Starch, Talc, Titanium Dioxide.

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 

Principal Display Panel
Ibuprofen 200mg
When Using This Product

take with food or milk if stomach upset occurs

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 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 right away. (1-800-222-1222)

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 
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

Use(s)

temporarily relieves minor aches and pains due to:

  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches n 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 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. 

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
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-Friday 9 AM – 5 PM EST)

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

Ibuprofen USP, 200mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

Colloidal Silicon Dioxide, Croscarmellose Sodium, D&C Yellow #10, FD&C Blue #2, FD&C Yellow #6,

Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized

Starch, Talc, Titanium Dioxide.

Do Not Use If You Have (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 

Principal Display Panel
Ibuprofen 200mg
When Using This Product (When using this product)

take with food or milk if stomach upset occurs

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 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 right away. (1-800-222-1222)

Ask A Doctor Before Use If You (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 
Ask A Doctor Or Pharmacist Before Use If (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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