BIOGESIC- acetaminophen, dexbrompheniramine maleate tablet 
Advanced Generic Corporation

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 ingredients (in each caplet)                      Purpose

Acetaminophen 500 mg                                            Pain Reliever/Fever Reducer

Dexbrompheniramine maleate 1 mg                            Antihistamine

Purpose

Antihistamine

Nasal Decongestant

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 

Do not use

Ask a doctor before use:

Stop using this product and ask a doctor if:

Warnings:

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. 

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.

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

Directions: Do not exceed recommended dosage

adults and children
12 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 under
12 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.

Uses

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

Questions or comments?

1-305-403-3788

Biogesic

BIOGESIC 
acetaminophen, dexbrompheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-610
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE1 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeOVALSize21mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45737-610-10100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/01/2017
Labeler - Advanced Generic Corporation (831762971)

Revised: 12/2020
Document Id: 8c3e3753-dfc7-4cfe-9c04-b7f8a8cfd75f
Set id: fdfebc9f-4775-4da4-9bb0-8175e67f93c4
Version: 2
Effective Time: 20201223
 
Advanced Generic Corporation