• 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.
• Do not exceed recommended dosage Adults and children 12 years of age and older Take 2 caplets every 4 to 6 hours as needed, do not exceed 8 caplets in 24 hours, or as directed by a doctor, do not use for more than 10 days unless directed by a doctor. Children under 12 years of age Do not use.
• Tamper Evident. Do not use if inner seal is torn, broken, or missing • Store at controlled room temperature 15°- 30°C (59°- 86°F) • Avoid excessive heat or humidity
www.actipharma.netAcetaminophen, 500 mg
Dexbrompheniramine Maleate, 1 mg
Pain reliever/Fever reducer
Antihistamine
• 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.
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 caplets (4,000 mg) 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
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash
• Caution: May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
Do not use • with any other drug containing acetaminophen (prescription or non-prescription) this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. 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.
Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.
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 lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur • redness or swelling is present
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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
Adults and children 12 years of age and older | Take 2 caplets every 4 to 6 hours as needed, do not exceed 8 caplets in 24 hours, or as directed by a doctor, do not use for more than 10 days unless directed by a doctor. |
| Children under 12 years of age | Do not use. |
• Tamper Evident. Do not use if inner seal is torn, broken, or missing
• Store at controlled room temperature 15°- 30°C (59°- 86°F)
• Avoid excessive heat or humidity
Magnesium stearate, microcrystalline cellulose, sodium starch glycolate.
Call weekdays from 8:00 AM - 4:00 PM, AST at 1-787-608-0882
Contains the same active ingredients as Dologesic®-DF*
SUGAR FREE
DYE FREE
ActiPharma
COMMITTED TO HEALTH AND WELL-BEING
Manufactured in the USA with imported ingredients for ActiPharma San Juan, PR 00917 Tel: (787) 608-0882
*Dologesic®-DF is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.www.actipharma.net
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63102-403-10 | 2023-10-10 | C162847 | 48780-1 | 0191ceaa-66bf-198a-e063-dbdaa90aec3e | ACTIDOGESIC ® - DF |
| 63102-403-10 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-66bf-198a-e063-dbdaa90aec3e | ACTIDOGESIC ® - DF |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63102-403-10 | ACTIDOGESIC DF | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 5 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63102-403-10 | EA - Each | 63102-403 | 59498c56-383c-4e13-b4c5-59f017cfa6da | 1 | 2023-06-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63102-403 | 63102-403-10 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXBROMPHENIRAMINE MALEATE | BPA9UT29BS | ACTIB |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
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 |
|---|---|---|---|---|---|---|
| ACTIDOGESIC DF | ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE | ACTIPHARMA, LLC | ff8e2565-bce3-4c06-a416-6e8f369f057f | 2025-07-09 | Warnings | 63102-403-10 63102-403 63102040310 d024a896-b400-4d33-a6aa-9643f823d4e2 ff8e2565-bce3-4c06-a416-6e8f369f057f |