Bioelectro®

Bioelectro®
SPL v1
SPL
SPL Set ID 683a0fba-921c-48e7-a391-180c04f0d1c4
Route
ORAL
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (65 mg) Caffeine
Inactive Ingredients
Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone K90 Starch, Corn Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AZ;285 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-26

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual & menstrual cramps
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

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.
Section 50568-5

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.
Section 50569-3

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.
Section 53414-9

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.

Section 55105-1
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
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
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.
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.
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.

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.

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.

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.
Principal Display Panel 24 Caplet Bottle Carton

Bio

Electro®

HEADACHE

EXTRA STRENGTH

Acetaminophen / Aspirin (NSAID) and Caffeine

Pain Reliever / Pain reliever aid

24 CAPLETS


Structured Label Content

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual & menstrual cramps
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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.
Section 50568-5 (50568-5)

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.
Section 50569-3 (50569-3)

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.
Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)
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
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
Do Not Use (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.
Allergy Alert (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 (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.
Reye's Syndrome (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.

Caffeine Warning (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.

Other Information (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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Stomach Bleeding Warning (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.
Principal Display Panel 24 Caplet Bottle Carton (PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton)

Bio

Electro®

HEADACHE

EXTRA STRENGTH

Acetaminophen / Aspirin (NSAID) and Caffeine

Pain Reliever / Pain reliever aid

24 CAPLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)