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Amerisource Bergen Migraine Relief Drug Facts

Approved
Approval ID

201f101a-3b53-4349-896c-6b86cdd9b831

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

Amerisource Bergen

DUNS: 007914906

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen, Aspirin, Caffeine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24385-365
Application NumberANDA075794
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen, Aspirin, Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (13)

ACETAMINOPHENActive
Quantity: 250 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
ASPIRINActive
Quantity: 250 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
CAFFEINEActive
Quantity: 65 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
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: 8/26/2025

Principal Display Panel

GOOD NEIGHBOR PHARMACY®

Compare to Excedrin® Migraine Relief active ingredients

Migraine Relief

Acetaminophen, Aspirin (NSAID) and Caffeine Tablets

Pain Reliever/Pain Reliever Aid

actual size

50 Coated Caplets**

**Capsule-shaped tablets

![374-29-migraine-relief.jpg](/dailymed/image.cfm?name=374-29-migraine- relief.jpg&id=894906)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/25/2014

Use

treats migraine

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/29/2018

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/25/2014

Purposes

Pain reliever

Pain reliever aid

WARNINGS SECTION

LOINC: 34071-1Updated: 2/26/2023

Warnings

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 skin 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

asthma (wheezing)

shock

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 month.

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 heart beat.

Do not use

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

you have never had migraines diagnosed by a health professional

you have a headache that is different from your usual migraines

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 or 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 warning 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

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 a doctor if

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 stools

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,

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.

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: 5/29/2018

Directions

**do not use more than directed**

adults: take 2 caplets with a glass of water

if symptoms persist or worsen, ask your 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 SECTION

LOINC: 44425-7Updated: 8/25/2014

Other information

store at 20°-25°C (68°-77°F)

close cap tightly after use

read all product information before using. Keep this box for important information.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/17/2009

Inactive ingredients

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 11/25/2019

Questions or comments?

1-800-719-9260

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good neighbor pharmacy migraine relief - FDA Drug Approval Details