BI ELECTRO EXTRA STRENGTH- acetaminophen/diphenhydramine hcl caplets tablet

Bi Electro by

Drug Labeling and Warnings

Bi Electro by is a Otc medication manufactured, distributed, or labeled by Genomma Labs USA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

BI ELECTRO  EXTRA STRENGTH
acetaminophen/diphenhydramine hcl caplets tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-267
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	AZ267
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-267-24	1 in 1 CARTON	12/23/2014
1		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	12/23/2014

Labeler - Genomma Labs USA, Inc (832323534)