Ibuprofen: Package Insert and Label Information

IBUPROFEN- ibuprofen tablet, film coated
Spirit Pharmaceuticals LLC

Drug Facts

Active Ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug


Pain reliever/fever reducer


• temporarily relieves minor aches and pains due to: • headache • toothache • backache
• menstrual cramps • the common cold • muscular aches • minor pain of arthritis • temporarily reduces fever


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 a nonsteroidal anti-inflammatory drug (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: NSAID’s except aspirin increases 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 any other pain reliever/fever reducer • right before or after heart surgery

Ask a doctor before use if • the stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • 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 • under a doctor’s care for any serious condition
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

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
• 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 breast-feeding, 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).


• do not take more than directed • the smallest effective dose should be used • adults and children 12 years and over: 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

Other Information

• read all warnings and directions before use. Keep carton. • store between 20°-25°C (68°-77°F) • avoid excessive heat above 40°C (104°F)

Inactive ingredients

colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, povidone K-30,pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Questions or comments?


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Compare to Advil® Tablets active ingredient†

Ibuprofen Tablets, 200 mg
Pain Reliever / Fever Reducer (NSAID)

30 tablets


Ibu Label 30 ct
(click image for full-size original)


Ibu Carton 30 ct
(click image for full-size original)
ibuprofen tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4199
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
Product Characteristics
Color brown Score no score
Shape ROUND Size 10mm
Flavor Imprint Code IBU;200
# Item Code Package Description Multilevel Packaging
1 NDC:68210-4199-3 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (68210-4199-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079129 06/15/2022
Labeler — Spirit Pharmaceuticals LLC (179621011)

Revised: 11/2022 Spirit Pharmaceuticals LLC

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