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Acetaminophen and Ibuprofen Back Pain

ACETAMINOPHEN AND IBUPROFEN BACK PAIN

Approved
Approval ID

32562aa1-f44b-649e-e063-6394a90a47c8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 9, 2025

Manufacturers
FDA

Granules Pharmaceuticals Inc.

DUNS: 079825711

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen and Ibuprofen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70010-213
Application NumberANDA216592
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateApril 9, 2025
FDA Product Classification

INGREDIENTS (21)

CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ACETAMINOPHENActive
Quantity: 250 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
IBUPROFENActive
Quantity: 125 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/9/2025

PRINCIPAL DISPLAY PANEL-18's Container Carton Label

NDC 70010-213-26
** †Compare to the Active Ingredients**
** of Advil® Dual Action Back Pain**
** Contains 2 Medicines**
** Acetaminophen and**
** Ibuprofen (NSAID)**
** Tablets**
** 250 mg/125 mg**
** Dual ActionPain Reliever
Back Pain****
** 8 Hour Relief

** 18 Caplets***
** (capsule-shaped tablets)*

![ibu-apap-18s-cont-carton](/dailymed/image.cfm?name=Ibu-apap-18s-cont- carton.jpg&id=874662)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/9/2025

Uses

• temporarily relieves minor aches and pains due to:
o backache

o muscular aches

o minor pain of arthritis
o headache
o toothache
o menstrual cramps

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/9/2021

Active ingredients (in each caplet)

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID**)

**nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/9/2021

Purposes

Pain reliever

Pain reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 11/9/2021

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.

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

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

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

When using this product

• Take with food or milk if stomach upset occurs

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/9/2021

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 4/20/2022

Questions or comments?

call1-877-770-3183Mon-Fri 8:00 AM EST to 5:00 PM PST.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/9/2021

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.

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Acetaminophen and Ibuprofen Back Pain - FDA Drug Approval Details