Other
Drug Facts
Packaged and distributed by Lil' Drug Store Products, Inc., 9300 Earhart Ln SW, Cedar Rapids, IA
The following Structured Product Label (SPL) was submitted to the FDA by Lil' Drug Store Products, Inc. for the product Excedrin Migraine (NDC 66715-9749). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, use, reye's syndrome, allergy alert, liver warning, stomach bleeding warning, medication overuse headache warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Packaged and distributed by Lil' Drug Store Products, Inc., 9300 Earhart Ln SW, Cedar Rapids, IA
| 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 |
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:
If a skin reaction occurs, stop use and seek medical help right away.
Aspirin may cause a severe allergic reaction which may include:
This product contains acetaminophen. Severe liver damage may occur if you take
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
Headaches may worsen if this product is used for 10 or more days per month.
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.
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.
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
1-800-468-7746
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.