Label: ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG- acetaminophen 250 mg and ibuprofen 125 mg tablets tablet, film coated
- NDC Code(s): 25000-080-07, 25000-080-72, 25000-080-74
- Packager: MARKSANS PHARMA LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 11, 2023
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 caplet)
- 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 caplets in 24 hours, which is the maximum daily amount for this product
• 3 or more alcoholic drinks every day while using this product
Acetaminophen allergy alert: may cause severe skin reactions. Symptoms may include:
• skin reddening
• blisters
• rash
If 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
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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
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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?
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PRINCIPAL DISPLAY PANEL
NDC 25000-080-72
Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
18 count carton label
NDC 25000-080-72
Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
18 count bottle label
NDC 25000-080-07
Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
90 count carton label
NDC 25000-080-07
Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
90 count bottle label
NDC 25000-080-74
Acetaminophen 250 mg and Ibuprofen 125 mg Tablets
288 count bottle label
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG
acetaminophen 250 mg and ibuprofen 125 mg tablets tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-080 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TRIACETIN (UNII: XHX3C3X673) POLYDEXTROSE (UNII: VH2XOU12IE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color YELLOW Score no score Shape CAPSULE Size 15mm Flavor Imprint Code 80 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-080-72 1 in 1 CARTON 07/11/2023 1 18 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:25000-080-07 1 in 1 CARTON 07/11/2023 2 90 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:25000-080-74 288 in 1 BOTTLE; Type 0: Not a Combination Product 07/11/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216994 07/11/2023 Labeler - MARKSANS PHARMA LIMITED (925822975) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 MANUFACTURE(25000-080)