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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45737-610-10 | 2020-12-23 | C162847 | 48780-1 | 9d75b9d0-56b9-f424-e053-dadaa90a57ce | AGC-Biogesic Tab 610 |
| 45737-610-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-56b9-f424-e053-dadaa90a57ce | AGC-Biogesic Tab 610 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45737-610-10 | Biogesic | 100 in 1 BOTTLE | TABLET | 100 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Biogesic
- Acetaminophen, Dexbrompheniramine Maleate
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- MICROCRYSTALLINE CELLULOSE
- POVIDONE
- SILICON DIOXIDE
- CARBOXYMETHYLCELLULOSE SODIUM
- STARCH, CORN
- STEARIC ACID
- TALC
- ACETAMINOPHEN
- DEXBROMPHENIRAMINE MALEATE
- DEXBROMPHENIRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 45737-610 | 45737-610-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | L11K75P92J | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TALC | 7SEV7J4R1U | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXBROMPHENIRAMINE MALEATE | BPA9UT29BS | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 29bc2f0e-d303-7185-e063-6394a90ad816 | fdfebc9f-4775-4da4-9bb0-8175e67f93c4 | 2024-12-20 | Warnings | 29bc2f0e-d303-7185-e063-6394a90ad816 fdfebc9f-4775-4da4-9bb0-8175e67f93c4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
