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equate dual back pain reliever

Wal-Mart Dual Back Pain Reliever Drug Facts

Approved
Approval ID

af7e6478-177f-473d-9d14-1e78610b1a6e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 17, 2025

Manufacturers
FDA

WALMART INC.

DUNS: 051957769

Products 1

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

acetaminophen, ibuprofen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code79903-326
Application NumberANDA214836
Product Classification
M
Marketing Category
C73584
G
Generic Name
acetaminophen, ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateMay 17, 2025
FDA Product Classification

INGREDIENTS (15)

ACETAMINOPHENActive
Quantity: 250 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
IBUPROFENActive
Quantity: 125 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/17/2025

Package/Label Principal Display Panel

equateTM

Compare to Advil® Dual Action Back Pain active ingredients

DUAL ACTION

Dual Back Pain Reliever

Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets

Pain Reliever

8 HOUR Relief

CONTAINS 2 MEDICINES

Acetaminophen + Ibuprofen

Actual Size

72 CAPLETS†

†Capsule-Shaped Tablets

![dual-back-pain-reliever](/dailymed/image.cfm?name=dual-back-pain- reliever.jpg&id=876092)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/19/2024

Uses

temporarily relieves minor aches and pains due to:

backache 

muscular aches

minor pain of arthritis 

headache

toothache 

menstrual cramps

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/19/2024

Active ingredients (in each caplet)

Acetaminophen 250 mg

Ibuprofen 125 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/19/2024

Purposes

Pain reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 11/19/2024

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 (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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/17/2025

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/17/2025

Other information

read all warnings and directions before use. Keep carton.

store at 20-25°C (68-77°F)

avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/19/2024

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, ferric oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/17/2025

Questions or comments?

1-888-287-1915

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equate dual back pain reliever - FDA Drug Approval Details