Label: BIOELECTRO EXTRA STRENGTH DAYTIME PAIN RELIEF- acetaminophen, aspirin, and caffeine tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 1, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet )Purpose
    *
    Nonsteroidal anti-inflammatory drug
    Acetaminophen 250mgPain reliever
    Aspirin 250 mg (NSAID*)Pain reliever
    Caffeine 65 mgPain reliever aid
  • Uses

    For temporary relieves minor aches and pains due to:

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

    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 tablets 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.

    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.

    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.

    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.

    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) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or 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 tablets every 6 hours; not more than 8 tablets 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 box for important information
  • Inactive ingredients

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

  • Questions or comments?

    Call toll free 1 877 99 GENOM (43666)

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Genomma Lab USA Inc., Houston, TX 77027

  • PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton

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

    Bio
    Electro

    HEADACHE
    DAYTIME

    EXTRA STRENGTH

    24 Tablets

    Principal Display Panel - 24 Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    BIOELECTRO EXTRA STRENGTH   DAYTIME PAIN RELIEF
    acetaminophen, aspirin, and caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-286
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen250 mg
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin250 mg
    Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine65 mg
    Inactive Ingredients
    Ingredient NameStrength
    calcium carbonate (UNII: H0G9379FGK)  
    magnesium carbonate (UNII: 0E53J927NA)  
    magnesium oxide (UNII: 3A3U0GI71G)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    povidone, unspecified (UNII: FZ989GH94E)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AZ;285
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-286-241 in 1 CARTON05/27/2021
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34305/27/2021
    Labeler - Genomma Lab USA (832323534)