Label: ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG- acetaminophen 250 mg and ibuprofen 125 mg tablets tablet
- NDC Code(s): 51672-4258-1, 51672-4258-4
- Packager: Sun Pharmaceutical Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 10, 2026
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each tablet)
- Purposes
- Uses
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Warnings
Acetaminophen liver damage warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
• with other drugs containing acetaminophen
• more than 6 tablets in 24 hours, which is the maximum daily amount for this product
• 3 or more alcoholic drinks every day while using this productAcetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
• skin reddening
• blisters
• rashIf skin reaction occurs, stop use and seek medical help right away.
NSAID 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.NSAID 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 directedHeart 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
-
Ask a doctor before use if
• you have liver disease
• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers
• 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
- When using this product
-
Stop use and ask a doctor if
• you experience any of the following signs of stomach bleeding:
o feel faint
o vomit blood
o have bloody or black stools
o have stomach pain that does not get better
• you have symptoms of heart problems or stroke:
o chest pain
o trouble breathing
o weakness in one part or side of body
o slurred speech
o leg swelling
• pain gets worse or lasts more than 10 days
• redness or swelling is present in the painful area
• any new symptoms appear - If pregnant or breast-feeding
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG
acetaminophen 250 mg and ibuprofen 125 mg tablets tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-4258 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 125 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color yellow Score no score Shape OVAL Size 15mm Flavor Imprint Code T;II Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-4258-4 1 in 1 CARTON 03/15/2026 1 72 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:51672-4258-1 1 in 1 CARTON 03/15/2026 2 216 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA219053 03/15/2026 Labeler - Sun Pharmaceutical Industries, Inc. (146974886) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 manufacture(51672-4258)

