Excinol Migraine (Acetaminophen)

Manufacturer
America Medic & Science, LLC | Time Cap Laboratories, Inc.
Effective date
2019-01-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:19

Label at a glance#

ProductExcinol Migraine (Acetaminophen)
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure16 sections

Indications and uses

Relieves Migraine

Dosage and administration

Drink full glass of water with each dose adults and children 12 years and over: take two tablets every 6 hours; not more than 8 tablets in 24 hours children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Excinol Migraine (Acetaminophen)250 mg

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 250 mg
Aspirin 250 mg
Caffeine 65 mg

Purpose

OTC - PURPOSE SECTION

  • Ultra relief Migraine pain

Uses

INDICATIONS & USAGE SECTION

  • Relieves 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: 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 8 tablets 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.

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

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 you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for:

  • anticoagulation (thinning of the blood)
  • 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

When using this product

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding

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 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: do not take more than directed

DOSAGE & ADMINISTRATION SECTION

Drink full glass of water with each dose

  • adults and children 12 years and over: take two tablets every 6 hours; not more than 8 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before using. Keep this box for important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carnauba wax, FD&C blue # 1 al lake, hydroxypropylmethyl cellulose, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-855-470-6722

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Excinol Migraine (Acetaminophen)
250 mg

image descriptionimage description

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49638-107-302023-01-30C16284748780-1f386c649-b7cd-0266-e053-dadaa90a7c1aExcinol Migraine (Acetaminophen) 250 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49638-107-30Excinol Migraine (Acetaminophen)1 in 1 CARTONTABLET, DELAYED RELEASE11
49638-107-30Excinol Migraine (Acetaminophen)30 in 1 BOTTLETABLET, DELAYED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49638-107EXCINOL MIGRAINE (ACETAMINOPHEN) (ACETAMINOPHEN) TABLET, DELAYED RELEASE [AMERICA MEDIC & SCIENCE, LLC]1Legacy NDC, 2 package rows20190124_96c8eae2-9e3e-43ed-a3b8-86d0cac71443.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
49638-10749638-107-30

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

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
12e1c3f0-47fe-48c1-be74-37936a98359796c8eae2-9e3e-43ed-a3b8-86d0cac714432019-01-22WarningsExact identifier
spl id: 12e1c3f0-47fe-48c1-be74-37936a983597
spl set id: 96c8eae2-9e3e-43ed-a3b8-86d0cac71443

Reported adverse events (FAERS/openFDA)#

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