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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Extra Strength Headache Relief (NDC 0363-8992). 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, uses, reye's syndrome, allergy alert, liver warning, stomach bleeding warning, caffeine warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
| Active ingredient (in each tablet) | Purpose |
|---|---|
| Acetaminophen 250 mg | Pain reliever |
| Aspirin 250 mg (NSAID)
nonsteroidal anti-inflammatory drug | Pain reliever |
| Caffeine 65 mg | Pain reliever aid |
temporarily relieves minor aches and pains due to:
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.
Aspirin may cause a severe allergic reaction which may include:
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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
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.
Ask a doctor or pharmacist before use if you are taking
These could be signs of a serious condition
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. 1(800) 222-1222
colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc
1-888-333-9792
COMPARE TO THE ACTIVE
INGREDIENTS OF EXCEDRIN®
EXTRA STRENGTH*
EXTRA STRENGHT
HEADACHE RELIEF
ACETAMINOPHE, ASPIRIN (NSAID) AND CAFFEINE
100 TABLETSĀ
* Please review the disclaimer below.