SPL v1
SPL
SPL Set ID 62d7ce90-63a4-4383-87c9-3a458eac29bf
Route
ORAL
Published
Effective Date 2024-02-15
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Ibuprofen (125 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Hypromellose 2910 (15 Mpa.s) Lactose Monohydrate Sodium Starch Glycolate Type A Potato Palmitostearic Acid Titanium Dioxide Triacetin Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: AI;II Shape: capsule Color: yellow Size: 15 mm Score: 1
Marketing Status
ANDA Active Since 2024-03-26

Description

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

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

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

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

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.

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 ­
Drug Facts

Active ingredients (in each caplet)                                                                             

Acetaminophen USP 250 mg

Ibuprofen USP 125 mg (NSAID*)

*nonsteroidal anti-in­flammatory drug

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

colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose monohydrate, pregelatinized starch (corn), sodium starch glycolate, stearic acid, titanium dioxide, triacetin, yellow iron oxide

Questions Or Comments?

 Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Code: TS/DRUGS/16/2014

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
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
Package Label Principal Display Panel 250 Mg/125 Mg (10 Caplets Bottle Label)

AUROHEALTH



NDC 58602-895-03



CONTAINS 2 MEDICINES

Acetaminophen + Ibuprofen



Acetaminophen and Ibuprofen (NSAID)

Tablets 250 mg/125 mg



BACK PAIN



Pain Reliever



10 Caplets*

*Capsule-Shaped Tablets

Package Label Principal Display Panel 250 Mg/125 Mg (10 Caplets Bottle Carton Label)

AUROHEALTH



NDC 58602-895-03

 **Compare to the active ingredients of Advil

Dual Action With Acetaminophen Back Pain



CONTAINS 2 MEDICINES
 

Acetaminophen + Ibuprofen 



Acetaminophen and Ibuprofen (NSAID)

Tablets 250 mg/125 mg



BACK PAIN



Pain Reliever



8

HOUR

RELIEF



10 Caplets*

*Capsule-Shaped Tablets

Package Label Principal Display Panel 250 Mg/125 Mg Blister Carton (2 (1 X 2) Caplets)

AUROHEALTH

NDC 58602-895-61

 **Compare to the active ingredients of Advil

Dual Action With Acetaminophen Back Pain



CONTAINS 2 MEDICINES

Acetaminophen + Ibuprofen



Acetaminophen and Ibuprofen (NSAID)

Tablets 250 mg/125 mg



√    Backache                            √    Headache

√    Muscular Aches                  √    Toothache

√    Minor Pain of Arthritis         √    Menstrual Cramps



BACK PAIN



Pain Reliever



Each caplet contains Acetaminophen 250 mg

and Ibuprofen 125 mg



8

HOUR

RELIEF




2 Caplets*

*Capsule-Shaped Tablets


Structured Label Content

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

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.

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 ­
Drug Facts

Active ingredients (in each caplet)                                                                             

Acetaminophen USP 250 mg

Ibuprofen USP 125 mg (NSAID*)

*nonsteroidal anti-in­flammatory drug

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)

colloidal silicon dioxide, corn starch, hydroxypropyl methylcellulose, lactose monohydrate, pregelatinized starch (corn), sodium starch glycolate, stearic acid, titanium dioxide, triacetin, yellow iron oxide

Questions Or Comments? (Questions or comments?)

 Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)



Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Code: TS/DRUGS/16/2014

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
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
Package Label Principal Display Panel 250 Mg/125 Mg (10 Caplets Bottle Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg (10 Caplets Bottle Label))

AUROHEALTH



NDC 58602-895-03



CONTAINS 2 MEDICINES

Acetaminophen + Ibuprofen



Acetaminophen and Ibuprofen (NSAID)

Tablets 250 mg/125 mg



BACK PAIN



Pain Reliever



10 Caplets*

*Capsule-Shaped Tablets

Package Label Principal Display Panel 250 Mg/125 Mg (10 Caplets Bottle Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg (10 Caplets Bottle Carton Label))

AUROHEALTH



NDC 58602-895-03

 **Compare to the active ingredients of Advil

Dual Action With Acetaminophen Back Pain



CONTAINS 2 MEDICINES
 

Acetaminophen + Ibuprofen 



Acetaminophen and Ibuprofen (NSAID)

Tablets 250 mg/125 mg



BACK PAIN



Pain Reliever



8

HOUR

RELIEF



10 Caplets*

*Capsule-Shaped Tablets

Package Label Principal Display Panel 250 Mg/125 Mg Blister Carton (2 (1 X 2) Caplets) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg/125 mg Blister Carton (2 (1 x 2) Caplets))

AUROHEALTH

NDC 58602-895-61

 **Compare to the active ingredients of Advil

Dual Action With Acetaminophen Back Pain



CONTAINS 2 MEDICINES

Acetaminophen + Ibuprofen



Acetaminophen and Ibuprofen (NSAID)

Tablets 250 mg/125 mg



√    Backache                            √    Headache

√    Muscular Aches                  √    Toothache

√    Minor Pain of Arthritis         √    Menstrual Cramps



BACK PAIN



Pain Reliever



Each caplet contains Acetaminophen 250 mg

and Ibuprofen 125 mg



8

HOUR

RELIEF




2 Caplets*

*Capsule-Shaped Tablets


Advanced Ingredient Data


Raw Label Data

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