FDA.reportPublic FDA data

Migraine Relief

Manufacturer
Family Dollar (FAMILY WELLNESS)
Effective date
2026-01-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:35:38

Label at a glance#

ProductMigraine Relief
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure10 sections

Indications and uses

treats migraine

Dosage and administration

do not use more than directed adults: take 2 caplets with a glass of water if symptoms persist or worsen, ask a doctor do not take more than 2 caplets in 24 hours, unless directed by a doctor under 18 years of age: ask a doctor

Storage and handling

store at controlled room temperature 20º to 25ºC (68º to 77ºF) close cap tightly after use read all product information before using

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever

Pain reliever

Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

  • treats migraine

Warnings

WARNINGS SECTION

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

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

  • skin reddening
  • blisters
  • rash

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

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)

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

  • more than 2 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

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

Medication overuse headache warning: Headaches may worsen. If this product is used for 10 or more days per mounth.

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use

OTC - DO NOT USE SECTION

  • if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have never had migraines diagnosed by a health professional 
  • you have a headache that is different from you usual migraine
  • you have the worst headache of your life  
  • you have fever and stiff neck 
  • you have headaches beginning after or caused by head injury, exertion, coughing, bending
  • you experienced your first headache after the age of 50
  • you have daily headaches
  • you have a migraine so severe as to require bed rest
  • you have liver disease
  • stomach bleeding warnings applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have vomiting with your migraine headache

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug for
    • diabetes,
    • gout,
    • arthritis
    • under a doctor’s care for any serious condition
    • taking any other drug
    • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

Stop use and ask doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding 
    • feel faint
    • vomit blood
    • have bloody or black stool
    • have stomach pain that does not get better
  • your migraine is not relieved or worsens after first dose
  • new or unexpected symptoms occur
  • ringing in the ears or loss of hearing occurs

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use aspirin 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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

  • do not use more than directed
  • adults: take 2 caplets with a glass of water
  • if symptoms persist or worsen, ask a doctor
  • do not take more than 2 caplets in 24 hours, unless directed by a doctor
  • under 18 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 20º to 25ºC (68º to 77ºF)
  • close cap tightly after use
  • read all product information before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose,  polyethylene glycol, sodium stearyl fumarate, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENTS IN EXCEDRIN® MIGRAINE†

MIGRAINE RELIEF

Acetaminophen Aspirin and Caffeine Tablets, USP

250 mg, 250 mg and 65 mg

Pain reliever/Pain reliever aid

CAPLETS**

(**Capsule-shaped tablets)

†This product is not manufactured or distributed by GSK Consumer Healthcare Holdings (US) LLC, distributor of Excedrin® Migraine

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY

MIDWOOD BRANDS, LLC

500 VOLVO PKWY,

CHESAPEAKE, VA 23320

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY WELLNESS Migraine Relief
FAMILY WELLNESS Migraine Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSN3
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCD3
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130032251920790GTIN-13: 0032251920790
EAN-13: 0032251920790
GTIN-12: 032251920790
UPC-A: 032251920790
GTIN storage (14 digits): 00032251920790		migraine-relief-caplet-grn-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-970-10Migraine Relief1 in 1 BOXTABLET13
55319-970-10Migraine Relief100 in 1 BOTTLE, PLASTICTABLET1003
55319-970-24Migraine Relief24 in 1 BOTTLE, PLASTICTABLET243
55319-970-24Migraine Relief1 in 1 BOXTABLET13

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
55319-97055319-970-24, 55319-970-10
62207-680

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ASPIRINR16CO5Y76EACTIB
CAFFEINE3G6A5W338EACTIB
CARNAUBA WAXR12CBM0EIZIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
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
A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINEACETAMINOPHEN; ASPIRIN; CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23

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
2026-09-14 22:38:342026-08A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-2384e616aacf4f…
2026-08-18 06:07:402026-07A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-2387673890dc5c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214039-001ACETAMINOPHEN, ASPIRIN AND CAFFEINE250MG;250MG;65MGTABLET / ORAL2021-02-23a50c72e98297…

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
Migraine ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEFamily Dollar (FAMILY WELLNESS)bfcffa70-94a9-43de-9f22-4ed6a71c0a8d2026-01-29WarningsExact identifier
ndc (package): 55319-970-24
ndc (package): 55319-970-10
ndc (product): 55319-970
ndc11 (package): 55319097010
ndc11 (package): 55319097024
spl id: 22241b86-a044-4b9c-b7b2-687a4c3faa0c
spl set id: bfcffa70-94a9-43de-9f22-4ed6a71c0a8d

Reported adverse events (FAERS/openFDA)#

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