Dual Pain Reliever

Dual Pain Reliever
SPL v5
SPL
SPL Set ID e457af7c-0fa7-a47e-e053-2a95a90abf9c
Route
ORAL
Published
Effective Date 2023-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Ibuprofen (125 mg)
Inactive Ingredients
Crospovidone Ferric Oxide Yellow Croscarmellose Sodium Ferric Oxide Red Hypromellose, Unspecified Povidone K90 Stearic Acid Polyethylene Glycol 400 Carnauba Wax Magnesium Stearate Microcrystalline Cellulose Polydextrose Sodium Lauryl Sulfate Titanium Dioxide Starch, Corn Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G;131 Shape: capsule Color: yellow Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2023-07-19

Description

Acetaminophen 250mg Ibuprofen 125mg (NSAID)

Purpose

Pain Reliever Pain reliever


Medication Information

Purpose

Pain Reliever Pain reliever

Description

Acetaminophen 250mg Ibuprofen 125mg (NSAID)

Pdp

Uses

■ temporarily relieves minor aches and pains due to:



■ headache ■ toothache ■ backache

■ menstrual cramps ■ muscular aches ■ minor pain of arthritis

Purposes

Pain Reliever

Pain reliever

Directions

■ do not take more than directed

adults and children 12 years and over

■ take 2 caplets every 8 hours while symptoms persist

children under 12 years

■ ask a doctor

■ do not take more than 6 caplets 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

Other Information

■ read all warnings and directions before use. Keep carton.

■ store at 20 to 25°C (68 to 77°F)

■ avoid excessive heat above 40°C (104°F)

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

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

Questions Or Comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

When Using This Product

■ Take with food or milk if stomach upset occurs

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

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.



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

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.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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:

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.

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

Active Ingredients (in Each Caplet)

Acetaminophen 250mg

Ibuprofen 125mg (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

Pdp (PDP)

Uses

■ temporarily relieves minor aches and pains due to:



■ headache ■ toothache ■ backache

■ menstrual cramps ■ muscular aches ■ minor pain of arthritis

Purposes

Pain Reliever

Pain reliever

Directions

■ do not take more than directed

adults and children 12 years and over

■ take 2 caplets every 8 hours while symptoms persist

children under 12 years

■ ask a doctor

■ do not take more than 6 caplets 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

Other Information (Other information)

■ read all warnings and directions before use. Keep carton.

■ store at 20 to 25°C (68 to 77°F)

■ avoid excessive heat above 40°C (104°F)

Inactive Ingredients (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

Nsaid Allergy Alert: (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

Questions Or Comments? (Questions or comments?)

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

When Using This Product (When using this product)

■ Take with food or milk if stomach upset occurs

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

Acetaminophen 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.



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

If Pregnant 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.

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Nsaid Stomach Bleeding Warning: (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: (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.

Acetaminophen Liver Damage Warning: (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

Active Ingredients (in Each Caplet) (Active Ingredients (in each caplet))

Acetaminophen 250mg

Ibuprofen 125mg (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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