BIOGESIC- acetaminophen, dexbrompheniramine maleate tablet

Biogesic by

Drug Labeling and Warnings

Biogesic by is a Otc medication manufactured, distributed, or labeled by Advanced Generic Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each caplet)                      Purpose

Acetaminophen 500 mg                                            Pain Reliever/Fever Reducer

Dexbrompheniramine maleate 1 mg                            Antihistamine

PURPOSE

Purpose

Antihistamine

Nasal Decongestant

WARNINGS

Warnings:
Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your
doctor whether you should take acetaminophen or other pain relievers/fever reducers.
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

Do not use

• with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist 
• if you are allergic to acetaminophen or any of the inactive ingredients in the product
• for more than 10 days for pain, unless directed by a doctor
• for more than 3 days for fever, unless directed by a doctor.

Ask a doctor before use:

• if you have liver disease
• if you are taking the blood thinning drug warfarin.

Stop using this product and ask a doctor if:

• pain gets worse or last more than 10 days 
• fever gets worse or last more than 3 days 
• new symptoms occur n redness or swelling is present
• These could be signs of a serious condition.

Warnings:

• May cause drowsiness: alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product.
• Do not take this product if you are taking sedatives or tranquilizers, without consulting your doctor.
• Use caution when driving motor vehicle or operating machinery.

Overdose Warning: Taking more than recommended dose (overdose), may cause liver
damage. In case of accidental overdose, contact a physician or Poison Control Center
right away. Prompt medical attention is critical for adults as well as for children even if
you do not notice any signs or symptoms.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. 

Overdose Warning: Taking more than recommended dose (overdose), may cause liver
damage. In case of accidental overdose, contact a physician or Poison Control Center
right away. Prompt medical attention is critical for adults as well as for children even if
you do not notice any signs or symptoms.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a Health Professional before use.

DOSAGE & ADMINISTRATION

Directions: Do not exceed recommended dosage

• adults and children12 years of age and over:

  Take 2 caplets every 4-6 hours. Do not take more

  than 8 caplets in 24 hours, or as directed by a doctor.

• children under12 years of age:

  Do not use in children under 12 years of age.

  This will provide more than the recommended dose (overdose)

  of acetaminophen and could cause liver damage.

INDICATIONS & USAGE

Uses

• For the temporary relief of minor aches and pains associated with
• headache
• muscular aches
• backaches
• minor arthiritis pain
• common cold
• toothaches
• mentrual cramps
• temporarily reduces fever
• itchy and watery eyes due to hay fever

INACTIVE INGREDIENT

Inactive ingredients: dicalcium phasphate, microcrystalline cellulose, povidone, silicon dioxide, sodium carboxymethyl starch, starch, stearic acid, talc.

QUESTIONS

Questions or comments?

1-305-403-3788

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOGESIC 
acetaminophen, dexbrompheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45737-610
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP)	DEXBROMPHENIRAMINE MALEATE	1 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45737-610-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/01/2017

Labeler - Advanced Generic Corporation (831762971)