Your browser does not support JavaScript! BIOELECTRO DAY (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) TABLET [A&Z PHARMACEUTICAL, INC.]
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BIOELECTRO DAY (acetaminophen and aspirin and caffeine) tablet
[A&Z Pharmaceutical, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

ACTIVE INGREDIENTS

Acetaminophen 250mg

Aspirin 250mg

Caffeine 65mg

PURPOSES

Pain Reliever, pain reliever aid

USES

Temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • sinusitis
  • toothache
  • premenstrual and menstrual cramps

WARNINGS

Reye's syndrome: Children and teenagers who have or are recovering for 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: Aspirin may cause a severe allergic reaction, which 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
  • 3 or more alcoholic drinks every day while using this product
  • more or for a longer time than directed

Stomach bleedingwarning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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 beverage while taking this product because too much caffeine may cause nervousness, irritability, sleepleness, and, occasionally, rapid heartbeat.

Do Not Use

  • if you ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether 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.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center 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 in 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)
  • Read all product information before using.
  • do not use if imprinted safety seal under cap is broken or missing
  • You may report serious side effects to 1-888-952-0050

INACTIVE INGREDIENTS

corn starch, croscarmellose sodium, crospovidone, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide*. *May contain these ingredients.

QUESTIONS OR COMMENTS?

Call toll free 1 877 99 GENOM (43666)

PRINCIPAL DISPLAY PANEL

BioelectroDay24ctTabletslabel
BioelectroDay24ctTablets
BIOELECTRO DAY  
acetaminophen and aspirin and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:62211-285
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
STARCH, PREGELATINIZED CORN 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code NONE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62211-285-2424 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/18/2005
Labeler - A&Z Pharmaceutical, Inc. (926820705)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
NameAddressID/FEIBusiness Operations
A&Z Pharmaceutical, Inc.926820705manufacture(62211-285)

Revised: 6/2012
 
A&Z Pharmaceutical, Inc.

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