ibuprofen
Major Pharmaceuticals Ibuprofen Tablets, 200mg Drug Facts
230fd746-92e0-40b6-9a90-595812bd8a18
HUMAN OTC DRUG LABEL
Aug 20, 2025
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Ibuprofen 200mg Tablet
INDICATIONS & USAGE SECTION
Uses
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temporarily relieves minor aches and pains due to:
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headache
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muscular aches
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minor pain of arthritis
•
toothache
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backache
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the common cold
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menstrual cramps
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temporarily reduces fever
STORAGE AND HANDLING SECTION
Other information
•
read all warnings and directions before use
•
store at 20-25°C (68-77°F)
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avoid high humidity and excessive heat above 40°C (104°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
1-800-616-2471
How Supplied Section
HOW SUPPLIED
NDC: 71335-2068-1: 20 Tablets in a BOTTLE
NDC: 71335-2068-2: 15 Tablets in a BOTTLE
NDC: 71335-2068-3: 30 Tablets in a BOTTLE
NDC: 71335-2068-4: 100 Tablets in a BOTTLE
NDC: 71335-2068-5: 60 Tablets in a BOTTLE
NDC: 71335-2068-6: 50 Tablets in a BOTTLE
NDC: 71335-2068-7: 40 Tablets in a BOTTLE
NDC: 71335-2068-8: 10 Tablets in a BOTTLE
NDC: 71335-2068-9: 56 Tablets in a BOTTLE
NDC: 71335-2068-0: 90 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
WARNINGS SECTION
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
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rash
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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 chances are higher if you
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are age 60 or older
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have had stomach ulcers or bleeding problems
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take a blood thinning (anticoagulant) or steroid drug
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take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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have 3 or more alcoholic drinks every day while using this product
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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
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if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
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right before or after heart surgery
Ask a doctor before use if
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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
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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
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taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
•
under a doctor’s care for any serious condition
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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 bleeding:
•
feel faint
•
vomit blood
•
have bloody or black stools
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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
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slurred speech
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leg swelling
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pain gets worse or lasts more than 10 days
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fever gets worse or lasts more than 3 days
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redness or swelling is present in the painful area
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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).
DOSAGE & ADMINISTRATION SECTION
Directions
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**do not take more than directed**
•
**the smallest effective dose should be used**
Adults and children 12 years and older:
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take 1 caplet every 4 to 6 hours while symptoms persist
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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