8 hr 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

Label at a glance#

Product8 hr Pain Relief
Active ingredientACETAMINOPHEN
Label structure9 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)
Acetaminophen 650 mg

OTC - PURPOSE SECTION

Purpose
Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions
Do not take more than directed.
See overdose warning
adults and children 12 years and over

• 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
children under 12 years

• do not use

STORAGE AND HANDLING SECTION

Other information
• store at 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

704R-DG-APAP-50s-Label704R-DG-APAP-50s-Label704R-DG-APAP-50s-ifc704R-DG-APAP-50s-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
55910-895-058 hr Pain Relief1 in 1 BOTTLETABLET, EXTENDED RELEASE12
55910-895-058 hr Pain Relief50 in 1 BOTTLETABLET, EXTENDED RELEASE502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-8958 HR PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [DOLGENCORP, INC.]2Current NDC, 2 package rows20230429_ea2ebb7b-ceab-567a-e053-2995a90aa402.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-89555910-895-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215486-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-254b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215486-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2021-08-25a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8 hr Pain ReliefACETAMINOPHENDOLGENCORP, INC.ea2ebb7b-ceab-567a-e053-2995a90aa4022023-04-20WarningsExact identifier
ndc (package): 55910-895-05
ndc (product): 55910-895
ndc11 (package): 55910089505
spl id: f9c35f34-c494-2573-e053-6294a90aee3a
spl set id: ea2ebb7b-ceab-567a-e053-2995a90aa402