Motrin® Dual Action With Tylenol®

Motrin® Dual Action With Tylenol®
SPL v7
SPL
SPL Set ID f2ee9cf5-02b7-6612-e053-2995a90a90c4
Route
ORAL
Published
Effective Date 2024-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (125 mg) Acetaminophen (250 mg)
Inactive Ingredients
Polyvinyl Alcohol, Unspecified Microcrystalline Cellulose Crospovidone, Unspecified Talc Povidone, Unspecified Titanium Dioxide Polyethylene Glycol, Unspecified Croscarmellose Sodium Silicon Dioxide Starch, Corn Sucralose Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: M;T Shape: oval Color: white Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2023-03-20

Description

Drug Facts

Purpose

Pain reliever Pain reliever


Medication Information

Purpose

Pain reliever Pain reliever

Description

Drug Facts

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ toothache

■ backache

■ menstrual cramps

■ muscular aches

■ minor pain of arthritis

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 53414-9

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.

Purposes

Pain reliever

Pain reliever

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

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

Questions?

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

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.

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

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

Principal Display Panel

NDC 50580-208-02

Motrin

8HR RELIEF

DUAL ACTION WITH TYLENOL

Acetaminophen 250 mg and

Ibuprofen (NSAID) 125 mg Tablets

Pain Reliever

DYE - FREE

actual size

20 Tablets

When Using This Product
  • take with food or milk if stomach upset occurs
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

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

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

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.

Active Ingredients (in Each Tablet)

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID *)

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


Structured Label Content

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ toothache

■ backache

■ menstrual cramps

■ muscular aches

■ minor pain of arthritis

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 53414-9 (53414-9)

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.

Purposes

Pain reliever

Pain reliever

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

Do Not Use (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

Questions?

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

Allergy Alert (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.

Other Information (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 (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

Liver Damage Warning: (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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50580-208-02

Motrin

8HR RELIEF

DUAL ACTION WITH TYLENOL

Acetaminophen 250 mg and

Ibuprofen (NSAID) 125 mg Tablets

Pain Reliever

DYE - FREE

actual size

20 Tablets

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning (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

Ask A Doctor Before Use If (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

Stop Use and Ask A Doctor If (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

Heart Attack and Stroke Warning (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.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID *)

Ask A Doctor Or Pharmacist Before Use If You Are (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


Advanced Ingredient Data


Raw Label Data

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