Ibuprofen (ibuprofen 200 mg) Dailymed

Drug Facts

Otc - Active Ingredient Section

Ibuprofen 200 mg (NSAID) *

nonsteroidal anti-inflammatory drug

Otc - Purpose Section

Pain reliever/ fever reducer

Indications & Usage Section

• 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 Section

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
• bulers

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.

Otc - Do Not Use Section

• 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 Section

• 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

Otc - Ask Doctor/pharmacist Section

• 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

Otc - When Using Section

• take with food or milk if stomach upset occurs

Otc - Stop Use Section

• 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 Section

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 Section

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

Dosage & Administration Section

• 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 at 20-25°C (68-77°F)[See USP Controlled Room Temperature]
• avoid high humidity and excessive heat above 40°C (104°F)

Inactive Ingredient Section

colloidal silicon dioxide, iron oxide red, maize starch, poly ethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

Otc - Questions Section

Call 1-877-770-3183: weekdays 9:00 AM to 4:30 PM EST

Manufactured By: Granules India Limited Hyderabad – 500 043, India MADE IN INDIA

M.L.No: 37/RR/AP/2003/F/R

Distributed By: Granules USA, Inc. Parsippany, NJ 07054

Recent Major Changes Section

Package Label.principal Display Panel

NDC# 62207-366-46

See New Warnings Information



IBUPROFEN TABLETS USP, 200 mg Pain Reliever/Fever Reducer (NSAID)*

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)

Do not use if foil inner seal is broken or missing.

250 Coated Caplets <sup>†

â€</sup> Capsule-Shaped Tablets

Important: Read all product information before using.

Do not use if the foil inner seal is broken or missing

NDC# 62207-366-47

Do not use if the foil inner seal is broken or missing See New Warnings Information



IBUPROFEN TABLETS USP, 200 mg Pain Reliever/Fever Reducer (NSAID)*

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)

Do not use if foil inner seal is broken or missing.

500 Coated Caplets†

†Capsule-Shaped Tablets

Important: Read all product information before using.

NDC# 62207-396-46

See New Warnings Information

IBUPROFEN TABLETS USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)*

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)

Do not use if foil inner seal is broken or missing.

250 Coated Caplets†

†Capsule-Shaped Tablets

Important: Read all product information before using.

NDC# 62207-396-46

Do not use if the foil inner seal is broken or missing

See New Warnings Information

IBUPROFEN TABLETS USP, 200 mg Pain Reliever/Fever Reducer (NSAID)*

Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)

Do not use if foil inner seal is broken or missing.

500 Coated Caplets†

†Capsule-Shaped Tablets

Important: Read all product information before using.