Label: IBUPROFEN tablet
- NDC Code(s): 69396-141-01, 69396-141-05
- Packager: Trifecta Pharmaceuticals USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 13, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)
- Purpose
- Do Not Use
- Uses
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Warnings
Allergy alert
Ibuprofen may cause severe allergic reactions, 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 NSAID, which may cause severe stomach bleeding. The chances are higher if you:
- are age 60 or older
- have stomach ulcers or bleeding problems
- take 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 or 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.
Contains FD+C Yellow No. 5 (tartrazine) as a color additive
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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, kidney disease, asthma, or had a stroke
- you are taking a diuretic
- Ask a doctor or pharmacist before use if you are
- Keep out of reach of children
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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 4-6 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 of age
- Ask a doctor
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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 body
- slurred speech
- leg swelling
- Pain gets worse or lasts more than 10 days
- Fever gets worse or lsats more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- If pregnant or breast-feeding
- Other Information
- Inactive Ingredients
- Questions or Comments?
- When using this product
- Distributed By:
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-141 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) MAGNESIUM STEARATE (UNII: 70097M6I30) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code BI06 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-141-01 50 in 1 BOX 08/08/2023 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:69396-141-05 10000 in 1 BAG 08/08/2023 2 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207095 08/08/2023 Labeler - Trifecta Pharmaceuticals USA LLC (079424163)