FDA.reportPublic FDA data

8 hr Arthritis Pain Relief

Manufacturer
DOLGENCORP, INC. | TIME CAP LABORATORIES, INC. | Marksans Pharma Ltd
Effective date
2023-04-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:48

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet) Acetaminophen 650 mg

OTC - PURPOSE SECTION

Purpose Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

Uses • temporarily relieves minor aches and pains due to: o minor pain of arthritis o muscular aches o backache o premenstrual and menstrual cramps o the common cold o headache o toothache • temporarily reduces fever

Warnings

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.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

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

Other Label Information

STORAGE AND HANDLING SECTION

Other information • store between 20-25ºC (68-77ºF) • The FDA approved Dissolution methods differ from USP

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

Label Images#

699R-DG-APAP-225s-Label
699R-DG-APAP-225s-Label
699R-DG-APAP-225s-ifc
699R-DG-APAP-225s-ifc
699R-DG-APAP-50s-Label
699R-DG-APAP-50s-Label
699R-DG-APAP-50s-ifc
699R-DG-APAP-50s-ifc
699R-DG-APAP-24s-Label
699R-DG-APAP-24s-Label
699R-DG-APAP-24s-ifc
699R-DG-APAP-24s-ifc

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN2
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD2
11483998 HR APAP 650 MG Extended Release Oral TabletSY2
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-892-058 hr Arthritis Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12
55910-892-058 hr Arthritis Pain Relief50 in 1 BOTTLETABLET, EXTENDED RELEASE502
55910-892-268 hr Arthritis Pain Relief225 in 1 BOTTLETABLET, EXTENDED RELEASE2252
55910-892-268 hr Arthritis Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12
55910-892-428 hr Arthritis Pain Relief24 in 1 BOTTLETABLET, EXTENDED RELEASE242
55910-892-428 hr Arthritis Pain Relief1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-8928 HR ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [DOLGENCORP, INC.]2Current NDC, 6 package rows20230429_ea2eae7c-e9bd-534c-e053-2a95a90a26c8.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-89255910-892-42, 55910-892-05, 55910-892-26

Ingredients#

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
STARCH, CORNO8232NY3SJIACT
POVIDONE K30U725QWY32XIACT
MAGNESIUM STEARATE70097M6I30IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TRIACETINXHX3C3X673IACT
CARNAUBA WAXR12CBM0EIZIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet) Acetaminophen 650 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Uses • temporarily relieves minor aches and pains due to: o minor pain of arthritis o muscular aches o backache o premenstrual and menstrual cramps o the common cold o headache o toothache • temporarily reduces fever

Warnings

WARNINGS SECTION

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.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Other information • store between 20-25ºC (68-77ºF) • The FDA approved Dissolution methods differ from USP

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

Source Document#

Source XML