Indications and uses
For the temporary relief of minor aches and pains associated with headache muscular aches backaches minor arthritis pain common cold toothaches menstrual cramps temporarily reduces fever itchy and watery eyes due to hay fever
For the temporary relief of minor aches and pains associated with headache muscular aches backaches minor arthritis pain common cold toothaches menstrual cramps temporarily reduces fever itchy and watery eyes due to hay fever
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...
(in each caplet)
Acetaminophen 500 mg
Dexbrompheniramine Maleate 1 mg
Pain reliever/fever reducer
antihistamine
Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take
Allergy Alert: Acetaminophen may cause sever skin reactions. Symptoms may incloude
If a skin reaction occurs, stop and seek medical help right away.
While using this product
Do not use
Ask a doctor before use:
Stop using this product and ask a doctor if:
Keep out of reach of children
If you are pregnant or breast-feeding, ask a health professional before use.
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 |
glycerin, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, tricalcium phosphate
1-866-595-5598
Added "itchy and watery eyes due to hay fever" in Uses
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54859-010-01 | 2020-12-23 | C162847 | 48780-1 | 9d75b9d0-40d8-f424-e053-dadaa90a57ce | Llorens-DologesicDFTab 010 |
| 54859-010-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-40d8-f424-e053-dadaa90a57ce | Llorens-DologesicDFTab 010 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54859-010-01 | DologesicDF | 100 in 1 BOTTLE | TABLET | 100 | 7 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54859-010-01 | EA - Each | 54859-010 | 7702918d-6dcc-4b1e-ad35-95d58fb7267f | 1 | 2016-07-19 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54859-010 | 54859-010-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| HYDROXYPROPYL METHYLCELLULOSE | 3NXW29V3WO | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| TRICALCIUM PHOSPHATE | K4C08XP666 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXBROMPHENIRAMINE MALEATE | BPA9UT29BS | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Dologesic DF | ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE | Llorens Pharmaceutical International Division | 55768b45-fd98-4779-85b6-6a50c628677e | 2025-12-31 | Warnings | 54859-010-01 54859-010 54859001001 47460679-895e-b4d5-e063-6394a90ab919 55768b45-fd98-4779-85b6-6a50c628677e |
Adverse event summaries are temporarily unavailable. Other product information remains available.