Bioelectro Extra Strength Headache Relief Tablet
FDA Label NDC 50066-630

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

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.

Other

Drug Facts

Distributed by:
Genomma Lab USA Inc., Houston,
TX 77098

Otc - Purpose

Active ingredients (in each caplet )Purpose
Acetaminophen 250 mgPain reliever
Aspirin 250 mg (NSAID

Nonsteroidal anti-inflammatory drug

)
Pain reliever
Caffeine 65 mgPain reliever aid

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual & menstrual cramps

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 such as

  • reddening
  • blisters
  • rash.
  • 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.

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 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.

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 heartbeat.

Do Not Use

  • if you ever had an allergic reaction to acetaminophen, aspirin, or any 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.

Otc - Ask Doctor

Ask a doctor before use if

  • you have liver disease
  • the 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 have asthma
  • you are taking a diuretic.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking

  • any other drug containing an NSAID (prescription or nonprescription)
  • a blood thinning (anticoagulant) or steroid drug
  • a prescription drug for diabetes, gout or arthritis
  • any other drug, or are under a doctor's care for any serious condition.

Otc - Stop Use

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.
  • ringing in the ears or loss of hearing occurs
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever get worse or lasts for more than 3 days
  • any new symptoms appear.

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 (1-800-222-1222). Quick medical attention is critical even if there are no symptoms.

Directions

  • do not use more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
  • children under 12 years: ask a doctor

Other Information

  • store at room temperature 20-25°C (68°-77°F)
  • close cap tightly after use
  • read all product information before using. Keep this carton for Drug facts.

Inactive Ingredients

hypromellose, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, stearic acid, talc

Questions Or Comments?

1-877-994-3666 Monday to Friday from 8 am to 6 pm, Central Time.

Principal Display Panel - 24 Caplet Bottle Carton

Bio
Electro®

HEADACHE

EXTRA STRENGTH

Acetaminophen / Aspirin (NSAID) and Caffeine
Pain Reliever / Pain reliever aid

24 CAPLETS

Principal Display Panel (24 Caplet Bottle Carton)

Principal Display Panel (24 Caplet Bottle Carton)

* Please review the disclaimer below.