FDA.reportPublic FDA data

Midol Long Lasting Relief

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:19:49

Label at a glance#

ProductMidol Long Lasting Relief
Active ingredientACETAMINOPHEN
Label structure16 sections

Indications and uses

Uses Temporarily relieves minor aches and pains due muscular aches backache minor pain of athritis toothache premenstrual and mentrual cramps headache the common cold temporarily reduces fever

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (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
  • muscular aches
  • backache
  • minor pain of athritis
  • toothache
  • premenstrual and mentrual cramps
  • headache
  • the common cold
  • temporarily reduces fever

WARNINGS SECTION

Warnings

Liver warning: The 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 cuse 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 not sure whether a drug contains acetaminophen, as a doctor or pharmacist.
  • If you are allergic to acetaminophen or any of the inactive ingredients in this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

As 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.

Directions

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

Other information

OTHER SAFETY INFORMATION

Other information

  • store at 20-25° (68-77°F). Avoid excessive heat 40°C (104°F).
  • do not use if printedfoil under cap is broken or missing

INACTIVE INGREDIENT SECTION

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

Questions or comments

OTC - QUESTIONS SECTION

Questions or comments? 1-800-331-4536

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Midol Long Lasting relief 20ct CartonMidol Long Lasting relief 20ct Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN8
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD8
11483998 HR APAP 650 MG Extended Release Oral TabletSY8
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-8090-20Midol Long Lasting Relief20 in 1 BOTTLETABLET, EXTENDED RELEASE208
0280-8090-20Midol Long Lasting Relief1 in 1 CARTONTABLET, EXTENDED RELEASE18

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-80900280-8090-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CARNAUBA WAXR12CBM0EIZIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MALTODEXTRIN7CVR7L4A2DIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONEFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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 43.

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
A075077-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2584e616aacf4f…
2026-08-18 06:07:402026-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-253f01610625f2…
2019-09-15 20:21 UTC2019-09A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25f41ea6bd6efb…

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
Midol Long Lasting ReliefACETAMINOPHENBayer HealthCare LLC.4a3a711d-c882-3525-e054-00144ff8d46c2025-12-04WarningsExact identifier
ndc (package): 0280-8090-20
ndc (product): 0280-8090
ndc11 (package): 00280809020
spl id: 4526b6bf-f3eb-0e65-e063-6394a90a6238
spl set id: 4a3a711d-c882-3525-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.