A+health Acetaminophen And Ibuprofen Tablets

A+health Acetaminophen And Ibuprofen Tablets
SPL v4
SPL
SPL Set ID 04ccc4b2-0cfd-3012-e063-6394a90afa79
Route
ORAL
Published
Effective Date 2025-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AI Shape: capsule Color: yellow Size: 15 mm Score: 1
Marketing Status
ANDA Active Since 2023-09-08

Description

Acetaminophen, USP 250 mg Ibuprofen, USP 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever Pain reliever


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • muscular aches
  • minor pain of arthritis
Purpose

Pain reliever Pain reliever

Dosage and Administration

Directions

■ do not take more than directed

adults and children 12 years and over take 2 caplets every 8 hourswhile 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

Acetaminophen, USP 250 mg Ibuprofen, USP 125 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Section 42229-5

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.

Section 44425-7

Other information

  • each caplet contains: sodium 3 mg
  • read all warnings and directions before use.
  • store at 20°C to 25°C (68°F to 77°F)
  • 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulphate, stearic acid, titanium dioxide

Section 53413-1

Questions or comments?

call toll-free 1-888-235-2466

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

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
Principal Display Panel

***Compare to the active ingredient in

Advil® Dual Action with

Acetaminophen

a+health

dual action

pain reliever

acetaminophen and ibuprofen (NSAID)

tablets, 250 mg/125 mg

Contains 2 medicines

400 Caplets**

**capsule-shaped tablets

Front

Back Ply-1

Back Ply-2

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
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
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, USP 250 mg

Ibuprofen, USP 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

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

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 hourswhile 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

Section 42229-5 (42229-5)

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.

Section 44425-7 (44425-7)

Other information

  • each caplet contains: sodium 3 mg
  • read all warnings and directions before use.
  • store at 20°C to 25°C (68°F to 77°F)
  • 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, glyceryl dibehenate, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulphate, stearic acid, titanium dioxide

Section 53413-1 (53413-1)

Questions or comments?

call toll-free 1-888-235-2466

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

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
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

***Compare to the active ingredient in

Advil® Dual Action with

Acetaminophen

a+health

dual action

pain reliever

acetaminophen and ibuprofen (NSAID)

tablets, 250 mg/125 mg

Contains 2 medicines

400 Caplets**

**capsule-shaped tablets

Front

Back Ply-1

Back Ply-2

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
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
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, USP 250 mg

Ibuprofen, USP 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

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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