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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Headache Relief (NDC 70005-004). 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 ingredients (in each tablet) | 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.
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
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
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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
store at 25 °C (77°F) excursions permitted between 15-30°C(59-86°F)
hypromellose, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pregelatinized starch, silicon dioxide, stearic acid, talc
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
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Compare to the Active Ingredients in
EXCERDRIN EXTRA STRENGTH
Acetaminophen, Asprin (NSAID) and Caffeine
TO OPEN
PUSH IN TAB AND PULL OUT
25 Pouches of 2 Caplets Each
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