FDA Label for Ibuprofen Immediate Release

Boxed Warning

Important: Read all product information before using.

Keep the box for important information.

Otc - Active Ingredient

Active ingredient (in each Orange caplet**)

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

**capsule-shaped tablets

Otc - Purpose

Purpose

Pain reliever / fever reducer

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
  
  

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.

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       

Otc - Ask Doctor/Pharmacist

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

Other

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

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

Manufactured by:

Strides Pharma Science Limited,

Puducherry - 605 014, India.

PON/DRUGS/16 13 4193

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

January 2022

Otc - When Using

When using this product

• take with food or milk if stomach upset occurs

Otc - Stop Use

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
    
    

Otc - Pregnancy 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.

Otc - 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)

Storage And Handling

Other Information

• store between 20-25⁰C (68-77⁰F)
• do not use if carton is opened. Do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing

Inactive Ingredients

colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide, and triacetin

Questions Or Comments

Call 1-855-742-7868 (toll-free)