716r Target 11673-924 Acetaminophen 250 Mg And Ibuprofen 125 Mg Tablets

716r Target 11673-924 Acetaminophen 250 Mg And Ibuprofen 125 Mg Tablets
SPL v3
SPL
SPL Set ID e680652b-30d8-6009-e053-2995a90abe29
Route
ORAL
Published
Effective Date 2023-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (125 mg) Acetaminophen (250 mg)
Inactive Ingredients
Glyceryl Dibehenate Croscarmellose Sodium Polydextrose Povidone Ferric Oxide Yellow Silicon Dioxide Microcrystalline Cellulose Ferric Oxide Red Triacetin Starch, Corn Hypromellose, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 80 Shape: capsule Color: yellow Size: 15 mm Score: 1
Marketing Status
ANDA Active Since 2023-07-11

Description

Active ingredients (in each caplet) Acetaminophen 250 mg Ibuprofen 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug


Medication Information

Warnings and Precautions

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: 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.

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.



Indications and Usage

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • toothache
  • backache
  • menstrual cramps
  • muscular aches
  • minor pain of arthritis

Dosage and Administration

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
Description

Active ingredients (in each caplet) Acetaminophen 250 mg Ibuprofen 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Section 44425-7

Other information

  • read all warnings and directions before use. Keep carton.
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat above 40°C (104°F)
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 50566-9

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



Section 50567-7

When using this product

• take with food or milk if stomach upset occurs



Section 50568-5

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



Section 50569-3

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

Section 50570-1

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



Section 51727-6

Inactive ingredients colloidal anhydrous silica, corn starch, croscarmellose sodium, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, povidone, red iron oxide, titanium dioxide, triacetin, yellow iron oxide.

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-910-6874

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.

Section 55105-1

Purposes

Pain reliever

Pain reliever

Section 55106-9

Active ingredients (in each caplet)

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • toothache
  • backache
  • menstrual cramps
  • muscular aches
  • minor pain of arthritis

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

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: 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.

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.



Section 44425-7 (44425-7)

Other information

  • read all warnings and directions before use. Keep carton.
  • store at 20-25ºC (68-77ºF)
  • avoid excessive heat above 40°C (104°F)
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 50566-9 (50566-9)

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



Section 50567-7 (50567-7)

When using this product

• take with food or milk if stomach upset occurs



Section 50568-5 (50568-5)

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



Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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



Section 51727-6 (51727-6)

Inactive ingredients colloidal anhydrous silica, corn starch, croscarmellose sodium, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, povidone, red iron oxide, titanium dioxide, triacetin, yellow iron oxide.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-910-6874

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.

Section 55105-1 (55105-1)

Purposes

Pain reliever

Pain reliever

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)