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NDC 54859-0010-01 Dologesic 500; 1 mg/1; mg/1 Details
Dologesic 500; 1 mg/1; mg/1
Dologesic is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Llorens Pharmaceutical International Division. The primary component is ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE.
Product Information
| NDC | 54859-0010 |
|---|---|
| Product ID | 54859-010_83ec16e9-3cd3-4d2e-8abe-494a28c65cb9 |
| Associated GPIs | 43992002170325 |
| GCN Sequence Number | 076023 |
| GCN Sequence Number Description | acetaminophen/d-brompheniramin TABLET 500MG-1MG ORAL |
| HIC3 | B5S |
| HIC3 Description | ANALGESIC, NON-SAL.- 1ST GENERATION ANTIHISTAMINE |
| GCN | 41262 |
| HICL Sequence Number | 038226 |
| HICL Sequence Number Description | ACETAMINOPHEN/DEXBROMPHENIRAMINE MALEATE |
| Brand/Generic | Brand |
| Proprietary Name | Dologesic |
| Proprietary Name Suffix | DF |
| 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 | Llorens Pharmaceutical International Division |
| 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 54859-0010-01 (54859001001)
| NDC Package Code | 54859-010-01 |
|---|---|
| Billing NDC | 54859001001 |
| Package | 100 TABLET in 1 BOTTLE (54859-010-01) |
| Marketing Start Date | 2016-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 55768b45-fd98-4779-85b6-6a50c628677e Details
Uses
Warnings
Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take
- more than 8 capsules in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminphen
- 3 or more alcoholic drinks every day while using this product
Alcohol Warning: If you consumer 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.
Do not use
- with any other drug containing acetaminphen (prescription or non-prescription). If you are not sure whether a drug contains acetaminphen 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
- May cause drowsiness: alcohol, sedative and tranquilizers may increase the drowsiness effect Avoid alcoholic beverages while taking this product
- Do not take this product if you are taking sedative or tranquilizers without consulting your doctore
- Use cauting when driving motor vehicle or operating machinery.
Ask a doctor or pharmacist before use:
- if you are taking the blood thinning drug warafin
- if you have liver disease
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
- redness or swelling is present
- these could be signs of a serious condition
SPL UNCLASSIFIED SECTION
Directions
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
Do not exceed recommended dosage
| Age | Dose |
| 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 acetaminphen and could cause liver damage |
Inactive ingredients
INGREDIENTS AND APPEARANCE
| DOLOGESIC
DF
acetaminophen, dexbrompheniramine maleate tablet |
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| Labeler - Llorens Pharmaceutical International Division (037342305) |
Revised: 12/2020
Document Id: 83ec16e9-3cd3-4d2e-8abe-494a28c65cb9
Set id: 55768b45-fd98-4779-85b6-6a50c628677e
Version: 4
Effective Time: 20201223