Your browser does not support JavaScript! EXCEDRIN MIGRAINE (ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE) TABLET, FILM COATED [NOVARTIS CONSUMER HEALTH, INC.]
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EXCEDRIN MIGRAINE (acetaminophen, aspirin (nsaid) and caffeine) tablet, film coated
[Novartis Consumer Health, Inc.]


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

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH

“SEALED for YOUR PROTECTION”IS BROKEN OR MISSING

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 tablets with a glass of water
  • if symptoms persist or worsen, ask your doctor
  • do not take more than 2 tablets in 24 hours, unless directed by a doctor
  • under 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.

TAMPER-EVIDENT BOTTLE

DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH

“SEALED for YOUR PROTECTION”IS BROKEN OR MISSING

 

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 or comments?

1-800-468-7746

Distr. By:

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

Principal Display

EXCEDRIN MIGRAINE CAPLETS

EXCEDRIN  MIGRAINE
acetaminophen, aspirin (nsaid) and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0067-2039
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
BENZOIC ACID 
CARNAUBA WAX 
CELLULOSE, MICROCRYSTALLINE 
FD&C BLUE NO. 1 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSE 
LIGHT MINERAL OIL 
POLYSORBATE 20 
POVIDONE 
PROPYLENE GLYCOL 
SORBITAN MONOLAURATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (White) Scoreno score
ShapeCAPSULE (Capsule shaped tablet) Size18mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-2039-07250 in 1 BOTTLE
2NDC:0067-2039-081 in 1 CARTON
28 in 1 BOTTLE
3NDC:0067-2039-241 in 1 CARTON
324 in 1 BOTTLE
4NDC:0067-2039-331 in 1 CARTON
4300 in 1 BOTTLE
5NDC:0067-2039-501 in 1 CARTON
550 in 1 BOTTLE
6NDC:0067-2039-771 in 1 CARTON
6250 in 1 BOTTLE
7NDC:0067-2039-831 in 1 CARTON
7125 in 1 BOTTLE
8NDC:0067-2039-84125 in 1 BOTTLE
9NDC:0067-2039-861 in 1 CARTON
9125 in 1 BOTTLE
10NDC:0067-2039-911 in 1 CARTON
10100 in 1 BOTTLE
11NDC:0067-2039-94100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02080202/15/2010
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 1/2010
 
Novartis Consumer Health, Inc.

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