SPL v1
SPL
SPL Set ID 1f4159ad-d58c-4519-932b-030cc2735514
Route
ORAL
Published
Effective Date 2017-05-26
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 Hypromelloses Titanium Dioxide Triacetin Fd&c Yellow No. 6 Talc

Identifiers & Packaging

Pill Appearance
Imprint: IBU200 Shape: capsule Shape: round Color: orange Color: white Size: 14 mm Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2011-04-04
Description

(ineach orange tablet or caplet ** ) Ibuprofen USP 200 mg (NSAID) * * nonsteroidal anti-inflammatory drug ** capsule-shaped tablets                               

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

(ineach orange tablet or caplet ** ) Ibuprofen USP 200 mg (NSAID) * * nonsteroidal anti-inflammatory drug ** capsule-shaped tablets                               

Use(s)
  • 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                


Warnings

Allergy alert:



Ibuprofen USP 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 non prescription 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 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 tablet or caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet or caplet, 2 tablets or caplets may be used
    • do not exceed 6 tablets or 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)
  • do not use if imprinted text "SEALED FOR YOUR PROTECTION" on the safety seal under cap is broken or missing
  • Sodium free 
  • Each tablet contains 0.714 mg of Magnesium
  • see end panel for lot number and expiration date.




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
Active Ingredient(s)

(ineach orange tablet or caplet ** )

Ibuprofen USP 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

**capsule-shaped tablets                               

Principal Display Panel


Package Label (Caplet Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets

See New Warnings

NDC 59556-856-41

Ibuprofen Tablets, USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Caplets**

**capsule-shaped tablets

*nonsteroidal anti-inflammatory drug





 











Package Label (Round Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets



See New Warnings

NDC 59556-855-41

Ibuprofen Tablets, USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Tablets

*nonsteroidal anti-inflammatory drug



























When Using This Product
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Inactive Ingredients (s)


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



QUESTIONS OR COMMENTS?

Call 1-855-742-7868 (toll-free): weekdays 8.00 AM to 8.00 PM EST



Manufactured by:

Strides Shasun Limited,

Puducherry - 605 014, India.

PON/DRUGS/16134193



Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816





May 2017





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 ad 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 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 in 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 breast-feeding, ask a health care professional before use. it is especially important not to use ibuprofen USP

 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 centre (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If
  • taking aspirin for heart attack or stroke, because ibuprofen USP may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug

Structured Label Content

Use(s) (USE(S))
  • 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                


Purpose (PURPOSE)

Pain reliever/fever reducer

Warnings (WARNINGS)

Allergy alert:



Ibuprofen USP 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 non prescription 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 failure, and stroke. these can be fatal. The risk is higher if you use more than directed or for longer than directed.

Directions (DIRECTIONS)
  • do not take more than directed
  • the smallest effective dose should be used

     adults and children 12 years and older
    •  take 1 tablet or caplet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet or caplet, 2 tablets or caplets may be used
    • do not exceed 6 tablets or 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)
  • do not use if imprinted text "SEALED FOR YOUR PROTECTION" on the safety seal under cap is broken or missing
  • Sodium free 
  • Each tablet contains 0.714 mg of Magnesium
  • see end panel for lot number and expiration date.




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
Active Ingredient(s) (ACTIVE INGREDIENT(S))

(ineach orange tablet or caplet ** )

Ibuprofen USP 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

**capsule-shaped tablets                               

Principal Display Panel (PRINCIPAL DISPLAY PANEL)


Package Label (Caplet Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets

See New Warnings

NDC 59556-856-41

Ibuprofen Tablets, USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Caplets**

**capsule-shaped tablets

*nonsteroidal anti-inflammatory drug





 











Package Label (Round Shaped Tablets) - Principal Display Panel - 24 - Count Bottle, 200 mg Tablets



See New Warnings

NDC 59556-855-41

Ibuprofen Tablets, USP

200 mg

Pain Reliever/Fever Reducer (NSAID)*

24 Coated Tablets

*nonsteroidal anti-inflammatory drug



























When Using This Product (WHEN USING THIS PRODUCT)
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Inactive Ingredients (s) (INACTIVE INGREDIENTS (S))


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



QUESTIONS OR COMMENTS?

Call 1-855-742-7868 (toll-free): weekdays 8.00 AM to 8.00 PM EST



Manufactured by:

Strides Shasun Limited,

Puducherry - 605 014, India.

PON/DRUGS/16134193



Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816





May 2017





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 ad 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 Doctor If (STOP USE AND ASK 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 in 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 breast-feeding, ask a health care professional before use. it is especially important not to use ibuprofen USP

 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 centre (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If (ASK A DOCTOR OR PHARMACIST BEFORE USE IF)
  • taking aspirin for heart attack or stroke, because ibuprofen USP 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:21.743310 · Updated: 2026-03-14T22:54:46.340416