Label: EXCEDRIN MIGRAINE- acetaminophen, aspirin and caffeine tablet, film coated
view more0067-8103-91, 0067-8103-92
- Packager: Novartis Consumer Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drugClose
Pain reliever aidClose
- treats migraines
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.
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Aspirin may cause a severe allergic reaction which may include:
- facial swelling
- asthma (wheezing)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 2 caplets 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
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 a 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:
- 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.
- 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)
- close cap tightly after use
- 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 dioxideClose
- Questions or comments?
- Package/Label Principal Display Panel
- INGREDIENTS AND APPEARANCE
acetaminophen, aspirin (nsaid) and caffeine tablet, film coated
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0067-8103 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg ASPIRIN (ASPIRIN) ASPIRIN 250 mg CAFFEINE (CAFFEINE) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength BENZOIC ACID CARNAUBA WAX FD&C BLUE NO. 1 HYDROXYPROPYL CELLULOSE (TYPE H) HYPROMELLOSES LIGHT MINERAL OIL CELLULOSE, MICROCRYSTALLINE POLYSORBATE 20 POVIDONES PROPYLENE GLYCOL DIMETHICONE SORBITAN MONOLAURATE STEARIC ACID TITANIUM DIOXIDE Product Characteristics Color WHITE (film coated) Score no score Shape CAPSULE (Capsule shaped tablet) Size 17mm Flavor Imprint Code EX Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8103-24 1 in 1 CARTON 1 24 in 1 BOTTLE 2 NDC:0067-8103-30 1 in 1 CARTON 2 30 in 1 BOTTLE 3 NDC:0067-8103-91 1 in 1 CARTON 3 100 in 1 BOTTLE 4 NDC:0067-8103-83 1 in 1 CARTON 4 125 in 1 BOTTLE 5 NDC:0067-8103-92 1 in 1 CARTON 5 200 in 1 BOTTLE 6 NDC:0067-8103-33 1 in 1 CARTON 6 300 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075794 10/22/2012 Labeler - Novartis Consumer Health, Inc. (879821635)