FDA Label for Excedrin Migraine
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USE
- REYE'S SYNDROME
- ALLERGY ALERT
- LIVER WARNING
- STOMACH BLEEDING WARNING
- MEDICATION OVERUSE HEADACHE WARNING
- CAFFEINE WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 6 CAPLET PACKET CARTON
Excedrin Migraine Product Label
The following document was submitted to the FDA by the labeler of this product Lil' Drug Store Products, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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) | Purposes |
---|---|
Acetaminophen 250 mg | Pain reliever |
Aspirin 250 mg (NSAID nonsteroidal anti-inflammatory drug ) | Pain reliever |
Caffeine 65 mg | Pain 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 reddening
- blisters
- rash
- hives
- facial swelling
- asthma (wheezing)
- shock
If a skin reaction occurs, stop use and seek medical help right away.
Aspirin may cause a severe allergic reaction which may include:
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
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 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:
- 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
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 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 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
Principal Display Panel - 6 Caplet Packet Carton
See new warnings information
EXCEDRIN®
MIGRAINE
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever / Pain Reliever Aid
6 Caplets
3 PACKETS OF 2 CAPLETS
*CAPSULE-SHAPED TABLETS
Lil'
DrugStore®
* Please review the disclaimer below.