Label: MOTRIN DUAL ACTION WITH TYLENOL- acetaminophen and ibuprofen tablet, film coated
- NDC Code(s): 50580-208-02, 50580-208-08, 50580-208-12, 50580-208-16
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 25, 2024
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- Active ingredients (in each tablet)
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Warnings
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 productAllergy alert
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.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
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
■ if you have ever had an allergic reaction to acetaminophen or any other pain reliever
■ right before or after heart surgeryAsk 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 diureticAsk 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 drugStop 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 - Directions
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INGREDIENTS AND APPEARANCE
MOTRIN DUAL ACTION WITH TYLENOL
acetaminophen and ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-208 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 POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) TALC (UNII: 7SEV7J4R1U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) SUCRALOSE (UNII: 96K6UQ3ZD4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape OVAL Size 14mm Flavor Imprint Code M;T Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-208-02 1 in 1 CARTON 03/20/2023 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:50580-208-08 1 in 1 CARTON 03/20/2023 2 80 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:50580-208-12 1 in 1 CARTON 03/20/2023 3 120 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:50580-208-16 2 in 1 CARTON 04/01/2024 4 1 in 1 CARTON 4 80 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 ANDA214836 03/20/2023 Labeler - Johnson & Johnson Consumer Inc. (878046358)