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NDC 45737-0610-10 Biogesic 500; 1 mg/1; mg/1 Details
Biogesic 500; 1 mg/1; mg/1
Biogesic is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Advanced Generic Corporation. The primary component is ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE.
Product Information
| NDC | 45737-0610 |
|---|---|
| Product ID | 45737-610_8c3e3753-dfc7-4cfe-9c04-b7f8a8cfd75f |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Biogesic |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dexbrompheniramine Maleate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 500; 1 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE |
| Labeler Name | Advanced Generic Corporation |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 45737-0610-10 (45737061010)
| NDC Package Code | 45737-610-10 |
|---|---|
| Billing NDC | 45737061010 |
| Package | 100 TABLET in 1 BOTTLE (45737-610-10) |
| Marketing Start Date | 2017-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL fdfebc9f-4775-4da4-9bb0-8175e67f93c4 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED 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.
SPL UNCLASSIFIED 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.
SPL UNCLASSIFIED 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. |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BIOGESIC
acetaminophen, dexbrompheniramine maleate tablet |
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| Labeler - Advanced Generic Corporation (831762971) |