Biogesic

Manufacturer
Advanced Generic Corporation
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:48:11

Label at a glance#

ProductBiogesic
Active ingredientACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each caplet)                      Purpose

Acetaminophen 500 mg                                            Pain Reliever/Fever Reducer

Dexbrompheniramine maleate 1 mg                            Antihistamine

OTC - PURPOSE SECTION

Purpose

Antihistamine

Nasal Decongestant

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?

1-305-403-3788

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BiogesicBiogesic

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1798453acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral TabletPSN3
1798453acetaminophen 500 MG / dexbrompheniramine maleate 1 MG Oral TabletSCD3
1798453APAP 500 MG / Dexbrompheniramine maleate 1 MG Oral TabletSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-610-102020-12-23C16284748780-19d75b9d0-56b9-f424-e053-dadaa90a57ceAGC-Biogesic Tab 610
45737-610-102020-01-31C16284748780-19d75b9d0-56b9-f424-e053-dadaa90a57ceAGC-Biogesic Tab 610

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-610-10Biogesic100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-610BIOGESIC (ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE) TABLET [ADVANCED GENERIC CORPORATION]3Legacy NDC, 1 package rows20241222_fdfebc9f-4775-4da4-9bb0-8175e67f93c4.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45737-61045737-610-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
29bc2f0e-d303-7185-e063-6394a90ad816fdfebc9f-4775-4da4-9bb0-8175e67f93c42024-12-20WarningsExact identifier
spl id: 29bc2f0e-d303-7185-e063-6394a90ad816
spl set id: fdfebc9f-4775-4da4-9bb0-8175e67f93c4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.