BIOELECTRO EXTRA STRENGTH HEADACHE RELIEF- acetaminophen, aspirin, and caffeine tablet

BioElectro Extra Strength Headache Relief by

Drug Labeling and Warnings

BioElectro Extra Strength Headache Relief by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA, Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each caplet )	Purpose
* Nonsteroidal anti-inflammatory drug
Acetaminophen 250 mg	Pain reliever
Aspirin 250 mg (NSAID*)	Pain reliever
Caffeine 65 mg	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 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.

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 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.

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

PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

Bio
Electro®

HEADACHE

EXTRA STRENGTH

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

24 CAPLETS

INGREDIENTS AND APPEARANCE

BIOELECTRO EXTRA STRENGTH HEADACHE RELIEF 
acetaminophen, aspirin, and caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-630
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D)	acetaminophen	250 mg
aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E)	aspirin	250 mg
caffeine (UNII: 3G6A5W338E) (caffeine - UNII:3G6A5W338E)	caffeine	65 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
microcrystalline cellulose (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE K90 (UNII: RDH86HJV5Z)
STARCH, CORN (UNII: O8232NY3SJ)
silicon dioxide (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AZ;285
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-630-24	1 in 1 CARTON	12/26/2025
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	12/26/2025

Labeler - Genomma Lab USA (832323534)

Establishment
Name	Address	ID/FEI	Business Operations
Allegiant Health		079501930	MANUFACTURE(50066-630) , PACK(50066-630) , LABEL(50066-630)