NDC 66715-9749 Excedrin Migraine

Acetaminophen, Aspirin, And Caffeine

NDC Product Code 66715-9749

NDC Code: 66715-9749

Proprietary Name: Excedrin Migraine 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, Aspirin, And Caffeine 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
18 MM
Imprint(s):
E
Score: 1

NDC Code Structure

  • 66715 - Lil' Drug Store Products, Inc.

NDC 66715-9749-3

Package Description: 3 POUCH in 1 CARTON > 2 TABLET, FILM COATED in 1 POUCH

NDC Product Information

Excedrin Migraine with NDC 66715-9749 is a a human over the counter drug product labeled by Lil' Drug Store Products, Inc.. The generic name of Excedrin Migraine is acetaminophen, aspirin, and caffeine. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Lil' Drug Store Products, Inc.

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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.

Excedrin Migraine 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.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
  • 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: Lil' Drug Store Products, Inc.
Labeler Code: 66715
FDA Application Number: NDA020802 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: NDA - A product marketed under an approved New Drug Application. 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: 08-15-2019 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.

Excedrin Migraine 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

Other

Drug Facts

Packaged and distributed by Lil' Drug Store Products, Inc., 9300 Earhart Ln SW, Cedar Rapids, IA

Otc - Purpose

Active ingredients (in each caplet)PurposesAcetaminophen 250 mgPain relieverAspirin 250 mg (NSAIDnonsteroidal anti-inflammatory drug)Pain relieverCaffeine 65 mgPain reliever aid

Use

  • Treats migraine

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

  • Aspirin may cause a severe allergic reaction which may include:hivesfacial swellingasthma (wheezing)shock

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if you takemore than 2 caplets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 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 youare 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

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 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 never had migraines diagnosed by a health professionalyou have a headache that is different from your usual migrainesyou have the worst headache of your lifeyou 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: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

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 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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Otc - Keep Out Of Reach Of Children

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 use more than directedadults: take 2 caplets with a glass of waterif symptoms persist or worsen, ask your doctordo not take more than 2 caplets in 24 hours, unless directed by a doctorunder 18 years of age: 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

Benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Questions?

1-800-468-7746

* Please review the disclaimer below.