Label: ACETAMINOPHEN AND IBUPROFEN tablet
- NDC Code(s): 51316-131-36, 51316-131-44, 51316-131-72
- Packager: CVS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 18, 2024
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- 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:
- NSAID allergy alert:
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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 directed - Heart attack and stroke warning:
- 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:
■ 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
■ 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
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Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and titanium dioxide.
- Questions or comments?
- Principal display panel
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN AND IBUPROFEN
acetaminophen and ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-131 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 125 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg Inactive Ingredients Ingredient Name Strength POLYDEXTROSE (UNII: VH2XOU12IE) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CROSPOVIDONE (UNII: 2S7830E561) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) CARNAUBA WAX (UNII: R12CBM0EIZ) POVIDONE K90 (UNII: RDH86HJV5Z) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color yellow (Light yellow to yellow colored) Score no score Shape CAPSULE (capsule shaped, biconvex) Size 14mm Flavor Imprint Code G;131 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-131-36 36 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2023 2 NDC:51316-131-72 72 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2023 3 NDC:51316-131-44 144 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216592 10/01/2023 Labeler - CVS (062312574)