Label: BIOGESIC- acetaminophen, dexbrompheniramine maleate tablet

  • NDC Code(s): 45737-610-10
  • Packager: Advanced Generic Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 23, 2020

If you are a consumer or patient please visit this version.

  • 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 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.

  • 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

    Biogesic

  • INGREDIENTS AND APPEARANCE
    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)