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Drug Facts
Motrin Dual Action With Tylenol Tablet, Film Coated
FDA Label NDC 50580-208
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Motrin Dual Action With Tylenol (NDC 50580-208). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients (in each tablet), purposes, uses, liver damage warning:, allergy alert, stomach bleeding warning, heart attack and stroke warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Tablet)
Acetaminophen 250 mg
Ibuprofen 125 mg (NSAID *)
Purposes
Pain reliever
Pain reliever
Uses
■ temporarily relieves minor aches and pains due to:
■ headache
■ toothache
■ backache
■ menstrual cramps
■ muscular aches
■ minor pain of arthritis
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 product
Allergy 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 surgery
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
■ 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 drug
When Using This Product
- take with food or milk if stomach upset occurs
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
■ do not take more than directed
| adults and children 12 years and over | ■ take 2 tablets every 8 hours while symptoms persist |
| children under 12 years | ■ ask a doctor |
■ do not take more than 6 tablets in 24 hours, unless directed by a doctor
Other Information
■ read all warnings and directions before use. Keep carton.
■ store at 20-25°C (68-77°F)
■ avoid excessive heat above 40°C (104°F)
Inactive Ingredients
colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide
Questions?
Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com
Principal Display Panel
NDC 50580-208-12
NEW
Motrin
DUAL ACTION WITH TYLENOL
Acetaminophen 250 mg and
Ibuprofen (NSAID) 125 mg Tablets
Pain Reliever
actual size
120 Tablets
Motrin-1 (Motrin 1)
* Please review the disclaimer below.
