NDC 49638-107 Excinol Migraine (acetaminophen)

Acetaminophen

NDC Product Code 49638-107

NDC Code: 49638-107

Proprietary Name: Excinol Migraine (acetaminophen) What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 49638 - America Medic & Science, Llc
    • 49638-107 - Excinol Migraine (acetaminophen)

NDC 49638-107-30

Package Description: 1 BOTTLE in 1 CARTON > 30 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC Product Information

Excinol Migraine (acetaminophen) with NDC 49638-107 is a a human over the counter drug product labeled by America Medic & Science, Llc. The generic name of Excinol Migraine (acetaminophen) is acetaminophen. The product's dosage form is tablet, delayed release and is administered via oral form.

Labeler Name: America Medic & Science, Llc

Dosage Form: Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Excinol Migraine (acetaminophen) Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 250 mg/1
  • ASPIRIN 250 mg/1
  • CAFFEINE 65 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: America Medic & Science, Llc
Labeler Code: 49638
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-17-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Excinol Migraine (acetaminophen) Product Label Images

Excinol Migraine (acetaminophen) Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Excinol Migraine (Acetaminophen)250 Mg

Drug Facts

Active Ingredient

Acetaminophen 250 mgAspirin 250 mgCaffeine 65 mg

Purpose

  • Ultra relief Migraine pain

Uses

  • Relieves Migraine

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: Aspirin may cause a severe allergic reaction which may include:hivesfacial swellingasthma (wheezing)shockLiver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 8 tablets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higherif you are age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake 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

  • If you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducerwith 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

  • You have never had migraines diagnosed by a health professionalyou have a headache that is different from your usual migrainesyou have the worst headache of your life you have fever and stiff neckyou have headaches beginning after or caused by head injury, exertion, coughing or bendingyou experienced your first headache after the age of 50you have daily headachesyou have a migraine so severe as to require bed restyou have liver diseasestomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have asthmayou have problems or serious side effects from taking pain relievers or fever reducersyou have vomiting with your migraine headache

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking a prescription drug for:anticoagulation (thinning of the blood)diabetesgoutarthritisunder a doctor’s care for any serious conditiontaking any other drugtaking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

When Using This Product

  • Stop use and ask a doctor ifan allergic reaction occurs. Seek medical help right away.you experience any of the following signs of stomach bleedingfeel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryour migraine is not relieved or worsens after first dosenew or unexpected symptoms occurringing in the ears or loss of hearing occurs

Keep Out Of Reach Of Children

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

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

Other Information

  • 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

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

* Please review the disclaimer below.

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