Label: IBUPROFEN- ibuprofen tablet, film-coated tablet, film coated
- NDC Code(s): 66715-9819-7
- Packager: Lil' Drug Store Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 8, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
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Warnings
Alergy Alert
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
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
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
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
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
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
Stop use and ask a doctor if
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 the 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
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.
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Directions
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
- Other information
- Inactive ingredients
- Questions or comments
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Principal Display Panel
[caduceus]
Compare to the Active
Ingredient in Advil ®*Ibuprofen
Pain Reliever/Fever Reducer
(NSAID), 200 mg*This product is not manufactured or distributed by
the Haleon group of companies. Lil’ Drug Store Products
does not own the Advil ® trademark.50 PACKETS OF 2 TABLETS
[barcode]
3 66715 97197 5
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, film-coated tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9819 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FERRIC OXIDE RED (UNII: 1K09F3G675) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;291 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-9819-7 50 in 1 BOX, UNIT-DOSE 09/12/2014 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075010 09/12/2014 Labeler - Lil' Drug Store Products, Inc. (093103646)