Label: IBUPROFEN tablet, coated
- NDC Code(s): 55319-568-10, 55319-568-25, 55319-568-50, 55319-568-52
- Packager: Family Dollar (FAMILY WELLNESS)
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 20, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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 any other pain reliever/fever reducer
- right before or after heart surgery
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, or kidney disease, asthma, or 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
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- you have symptoms of heart problem or stroke:
- chest pain
- slurred speech
- leg swellin
- trouble breathing
- weakness in one part or side of body
- 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
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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
COMPARE TO THE ACTIVE INGREDIENT OF ADVIL®†
Ibuprofen
Tablets USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)
COATED TABLETS
Gluten free
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil®.
TAMPER-EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
10611 MONROE RD., MATTHEWS, NC 28105
- Product Label
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-568 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) FERRIC OXIDE RED (UNII: 1K09F3G675) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code G2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-568-25 1 in 1 BOX 06/30/2017 04/26/2024 1 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:55319-568-10 1 in 1 BOX 06/30/2017 04/26/2024 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:55319-568-50 1 in 1 BOX 06/30/2017 04/26/2024 3 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 4 NDC:55319-568-52 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2017 04/26/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 06/30/2017 04/26/2024 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
