Label: BI ELECTRO EXTRA STRENGTH- acetaminophen 250 mg /aspirin 250 mg/caffeine 65 mg 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 December 3, 2018

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

  • Active ingredient

    Acetaminophen 250 mg
    Aspirin 250 mg (NSAID*)
    Caffeine 65 mg
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever
    Pain reliever
    Pain reliever aid

  • Uses

    Temporarily 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 a 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), 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
    • adult has 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 have ever had an allergic reaction to acetaminophen, aspirinor other pain relievers/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
    • 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 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 gets worse or lasts for more than 3 days
    • any new symptoms sppear

    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 specifically 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

    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 20-25ºC (68-77ºF)
    • close cap tightly after use
    • read all product information before using. Keep this carton for Drug facts.
  • Inactive Ingredients

    corn starch, croscarmellose sodium, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

  • Package/Label Principal Display Panel

    Bio Electro ES

    Bio Electro ES


  • INGREDIENTS AND APPEARANCE
    BI ELECTRO  EXTRA STRENGTH
    acetaminophen 250 mg /aspirin 250 mg/caffeine 65 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-285
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AZ285
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-285-241 in 1 CARTON01/08/2015
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34301/08/2015
    Labeler - Genomma Labs USA, Inc (832323534)