Ibuprofen Tablets 200mg (orange-round And Capsule Shaped) 

Ibuprofen Tablets 200mg (orange-round And Capsule Shaped) 
SPL v7
SPL
SPL Set ID 859d7190-586f-4766-a7e7-9e800a72d58b
Route
ORAL
Published
Effective Date 2021-12-29
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Cellulose, Microcrystalline Croscarmellose Sodium Starch, Pregelatinized Corn Talc Silicon Dioxide Magnesium Stearate Polyvinyl Alcohol Polyethylene Glycol 3350 Fd&c Yellow No. 6 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 115 Shape: capsule Shape: round Color: orange Size: 10 mm Size: 15 mm Score: 1
Marketing Status
ANDA Active Since 2015-11-06
Description

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

Purpose

Pain reliever/fever reducer

Medication Information

Purpose


Pain reliever/fever reducer

Description

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

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 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 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 ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery
Other Information
  •   store at 20-25ºC (68-77ºF)
  • do not use if carton is opened. Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing
  • see end panel for lot number and expiration date
Inactive Ingredient(s)


colloidal silicon dioxide, croscarmellose sodium, FD & C yellow # 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.



Questions or comments?

Call 1-877-290-4008



Manufactured for:

Time-Cap Labs, Inc.

7 Michael Avenue,

Farmingdale,

NY 11735, USA



Manufactured by:

Marksans Pharma Ltd.

Plot No. L-82, L-83,

Verna Indl. Estate,

Verna, Goa-403 722, India.

Active Ingredient(s)  


Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Principal Display Panel

NDC 25000-136-03, Ibuprofen Tablets, USP 200mg



30 counts Bottle Label











NDC 25000-136-03,Ibuprofen Tablets, USP 200mg



30 counts Carton Label









NDC 25000-135-03, Ibuprofen Tablets, USP 200mg (Caplets)



30 counts Bottle Label









NDC 25000-135-03, Ibuprofen Tablets, USP 200mg (Caplets)



30 counts Carton Label









NDC 25000-136-69, Ibuprofen Tablets, USP 200mg



300 counts Bottle Label









NDC 25000-136-14, Ibuprofen Tablets, USP 200mg



1000 counts Bottle Label









NDC 25000-136-71, Ibuprofen Tablets, USP 200mg



1000 counts (PET) Bottle Label







NDC 25000-135-14, Ibuprofen Tablets, USP 200mg (Caplets)



1000 counts Bottle Label





NDC 25000-135-70, Ibuprofen Tablets, USP 200mg (Caplets)



500 counts Bottle Label







NDC 25000-136-02, Ibuprofen Tablets, USP 200mg



24 counts Bottle Label





NDC 25000-136-02, Ibuprofen Tablets, USP 200mg



24 counts Carton Label





NDC 25000-135-02, Ibuprofen Tablets, USP 200mg (Caplets)



24 counts Bottle Label





NDC 25000-135-02, Ibuprofen Tablets, USP 200mg (Caplets)



24 counts Carton Label



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, 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 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 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 a 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 Or Pharmacist Before Use If
  • 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
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
  • 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 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 ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery
Other Information (Other information)
  •   store at 20-25ºC (68-77ºF)
  • do not use if carton is opened. Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing
  • see end panel for lot number and expiration date
Inactive Ingredient(s) (Inactive ingredient(s))


colloidal silicon dioxide, croscarmellose sodium, FD & C yellow # 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.



Questions or comments?

Call 1-877-290-4008



Manufactured for:

Time-Cap Labs, Inc.

7 Michael Avenue,

Farmingdale,

NY 11735, USA



Manufactured by:

Marksans Pharma Ltd.

Plot No. L-82, L-83,

Verna Indl. Estate,

Verna, Goa-403 722, India.

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


Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Principal Display Panel

NDC 25000-136-03, Ibuprofen Tablets, USP 200mg



30 counts Bottle Label











NDC 25000-136-03,Ibuprofen Tablets, USP 200mg



30 counts Carton Label









NDC 25000-135-03, Ibuprofen Tablets, USP 200mg (Caplets)



30 counts Bottle Label









NDC 25000-135-03, Ibuprofen Tablets, USP 200mg (Caplets)



30 counts Carton Label









NDC 25000-136-69, Ibuprofen Tablets, USP 200mg



300 counts Bottle Label









NDC 25000-136-14, Ibuprofen Tablets, USP 200mg



1000 counts Bottle Label









NDC 25000-136-71, Ibuprofen Tablets, USP 200mg



1000 counts (PET) Bottle Label







NDC 25000-135-14, Ibuprofen Tablets, USP 200mg (Caplets)



1000 counts Bottle Label





NDC 25000-135-70, Ibuprofen Tablets, USP 200mg (Caplets)



500 counts Bottle Label







NDC 25000-136-02, Ibuprofen Tablets, USP 200mg



24 counts Bottle Label





NDC 25000-136-02, Ibuprofen Tablets, USP 200mg



24 counts Carton Label





NDC 25000-135-02, Ibuprofen Tablets, USP 200mg (Caplets)



24 counts Bottle Label





NDC 25000-135-02, Ibuprofen Tablets, USP 200mg (Caplets)



24 counts Carton Label



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, 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 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 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 a 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 Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • 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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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:55.513550 · Updated: 2026-03-14T23:00:05.624312