BI ELECTRO EXTRA STRENGTH- acetaminophen/diphenhydramine hcl caplets tablet 
Genomma Labs USA, Inc

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.

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Drug Facts

Active ingredient

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

Pain reliever
Nighttime sleep aid

Uses

temporarily relieves occasional headaches and minor aches and pains with accompanying

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take more than one dose in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

Allergy alert
acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening
blisters rash. If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription).
  • If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacistwith any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age

Ask a doctor before use if you have

  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you

  • are taking the blood thinning drug warfarin
  • are taking sedatives or tranquilizers

When using this product

  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery
  • avoid alcoholic drinks

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • pain gets worse or lasts for more than 10 days
  • new symptoms occur
  • redness or swelling is present. These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use

Keep out of reach of children

Overdosage

Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose,
get medical help or contact a doctor or 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

Adults and children 12 years of age and older: Take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.

Children under 12 years of age: Do not use this adult product in children under 12 years of age, this will provide more than the recommended dose (overdose) and may cause liver damage.

Do not take more than directed (see overdose warning)

Inactive Ingredients

croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid, talc , titanium dioxide.

Package/Label Principal Display Panel

Bio Electro

Bio Electro

BI ELECTRO  EXTRA STRENGTH
acetaminophen/diphenhydramine hcl caplets tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-267
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code AZ267
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-267-241 in 1 CARTON12/23/201409/20/2022
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 finalpart34312/23/201409/20/2022
Labeler - Genomma Labs USA, Inc (832323534)

Revised: 11/2018
Document Id: 5af08766-1955-4be4-bfd8-1f2016504587
Set id: 1ae15feb-bd13-4aec-afc7-ff77de8b0256
Version: 8
Effective Time: 20181116
 
Genomma Labs USA, Inc