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Drug Facts
Distributed by:
Genomma Lab USA Inc., Houston,
TX 77098
The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Bioelectro Extra Strength Headache Relief (NDC 50066-630). 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
Distributed by:
Genomma Lab USA Inc., Houston,
TX 77098
| Active ingredients (in each caplet ) | 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.
Acetaminophen may cause severe skin reactions such as
If skin reactions occur, stop use and see a doctor right away. Aspirin may cause a severe allergic reaction, which may include: hives, facial swelling, asthma (wheezing), or shock.
This product contains acetaminophen. Severe liver damage may occur if you take:
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 heartbeat.
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are taking
Stop use and ask a doctor if
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 (1-800-222-1222). Quick medical attention is critical even if there are no symptoms.
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