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equate 8hr arthritis pain relief

Wal-Mart 8HR Arthritis Pain Relief Drug Facts

Approved
Approval ID

36a0cac6-f5d1-4679-8bef-d52577fc0d57

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 9, 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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code79903-345
Application NumberANDA075077
Product Classification
M
Marketing Category
C73584
G
Generic Name
acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2025
FDA Product Classification

INGREDIENTS (13)

ACETAMINOPHENActive
Quantity: 650 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/9/2025

Principal Display Panel

equate™

Compare to Tylenol® 8HR Arthritis Pain active ingredient

8HR Arthritis Pain Relief

Acetaminophen Extended-Release Tablets, 650 mg

Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Actual Size

650 mg EACH

325 CAPLETS*

*Capsule-Shaped Tablets

![equate-8hr-arthritis-pain-relief-container- image.jpg](/dailymed/image.cfm?name=equate-8hr-arthritis-pain-relief- container-image.jpg&id=880262)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/17/2025

Uses

temporarily relieves minor aches and pains due to:

minor pain of arthritis

muscular aches

backache

premenstrual and menstrual cramps

the common cold

headache

toothache

temporarily reduces fever

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/17/2025

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/17/2025

Active ingredient (in each caplet)

Acetaminophen 650 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/17/2025

Purpose

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 2/17/2025

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 6 caplets in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening

blisters

rash

If a skin reaction occurs, stop use and seek medical help right away.

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 are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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: 2/17/2025

Directions

**do not take more than directed (see overdose warning)**  

adults

take 2 caplets every 8 hours with water

swallow whole; do not crush, chew, split or dissolve

do not take more than 6 caplets in 24 hours

do not use for more than 10 days unless directed by a doctor

under 18 years of age

ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/9/2025

Other information

store at 20-25°C (68-77°F)

meets the requirements of USP Dissolution Test 4

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/9/2025

Questions or comments?

1-888-287-1915

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