Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 57a8dc2b-a3bc-49fa-b605-2330155bdbff
Route
ORAL
Published
Effective Date 2025-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (125 mg) Acetaminophen (250 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium Povidone K90 Silicon Dioxide Glyceryl Dibehenate Hypromellose 2910 (6 Mpa.s) Titanium Dioxide Polydextrose Polyethylene Glycol, Unspecified Ferric Oxide Red Ferric Oxide Yellow Shellac Ferrosoferric Oxide Propylene Glycol

Identifiers & Packaging

Pill Appearance
Imprint: G375 Shape: capsule Color: yellow Size: 15 mm Score: 1
Marketing Status
ANDA Active Since 2024-05-07

Description

Acetaminophen 250 mg Ibuprofen 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:
    • o
      headache
    • o
      toothache
    • o
      backache
    • o
      menstrual cramps
    • o
      muscular aches
    • o
      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 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

Acetaminophen 250 mg Ibuprofen 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

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

colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxides, glyceryl dibehenate, hypromellose, iron oxide yellow, iron oxide red, polydextrose, povidone, polyethylene glycol, propylene glycol, shellac, pregelatinized starch and titanium dioxide

Section 53413-1

Questions or comments?

call weekdays 9 AM to 5 PM at 1 (888) 721-7115

Distributed by:

Glenmark Therapeutics Inc., USA

Elmwood Park, NJ 07407

July 2025

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

NDC 72657-157-74

Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets

Pain Reliever

144’sCaplets*

*Capsule-Shaped Tablets

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:
    • o
      feel faint
    • o
      vomit blood
    • o
      have bloody or black stools
    • o
      have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • o
      chest pain
    • o
      trouble breathing
    • o
      weakness in one part or side of body
    • o
      slurred speech
    • o
      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 250 mg

Ibuprofen 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:
    • o
      headache
    • o
      toothache
    • o
      backache
    • o
      menstrual cramps
    • o
      muscular aches
    • o
      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

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

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

colloidal silicon dioxide, croscarmellose sodium, ferrosoferric oxides, glyceryl dibehenate, hypromellose, iron oxide yellow, iron oxide red, polydextrose, povidone, polyethylene glycol, propylene glycol, shellac, pregelatinized starch and titanium dioxide

Section 53413-1 (53413-1)

Questions or comments?

call weekdays 9 AM to 5 PM at 1 (888) 721-7115

Distributed by:

Glenmark Therapeutics Inc., USA

Elmwood Park, NJ 07407

July 2025

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)

NDC 72657-157-74

Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets

Pain Reliever

144’sCaplets*

*Capsule-Shaped Tablets

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:
    • o
      feel faint
    • o
      vomit blood
    • o
      have bloody or black stools
    • o
      have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • o
      chest pain
    • o
      trouble breathing
    • o
      weakness in one part or side of body
    • o
      slurred speech
    • o
      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 250 mg

Ibuprofen 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

All Sections (JSON)