Your browser does not support JavaScript! EXCEDRIN MIGRAINE (ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]
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RxNorm Names

EXCEDRIN MIGRAINE (acetaminophen, aspirin (nsaid) and caffeine) tablet, film coated
[Novartis Consumer Health, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredient

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

Caffeine 65 mg

* nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever

Pain reliever aid

Uses

treats 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:

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

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

  • more than 2 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

  • 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 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:
    • 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

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 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.

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 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

Other information

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

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

Questions or comments?

1-800-468-7746

Additional information

Distributed by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

©20XX

Visit us at www.excedrin.com

Tamper-Evident Feature: DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS BROKEN

OR MISSING

KEEP BOX FOR REFERENCE

Package/Label Principal Display Panel

Excedrin Migraine 24 ct carton
EXCEDRIN  MIGRAINE
acetaminophen, aspirin (nsaid) and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0067-8103
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSPOVIDONE 
FD&C BLUE NO. 1 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
PROPYLENE GLYCOL 
SACCHARIN SODIUM DIHYDRATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (film coated) Scoreno score
ShapeCAPSULE (Capsule shaped tablet) Size17mm
FlavorImprint Code EX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-8103-241 in 1 CARTON
124 in 1 BOTTLE
2NDC:0067-8103-911 in 1 CARTON
2100 in 1 BOTTLE
3NDC:0067-8103-921 in 1 CARTON
3200 in 1 BOTTLE
4NDC:0067-8103-331 in 1 CARTON
4300 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07579410/22/2012
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 10/2012
 
Novartis Consumer Health, Inc.

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