• 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, 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, 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.
Ask a doctor before use if you have
• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland
• glaucoma
Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers
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
These could be signs of a serious condition.
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
FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerol mono and dicaprylocaprate, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyvinyl alcohol graft polyethylene glycol copolymer, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Call weekdays from 8:00 AM - 4:00 PM, AST at 1-787-608-0882
• ANALGESIC • FEVER REDUCER • ANTIHISTAMINE
Contains the same active ingredients as Dologesic®
SUGAR FREE
ActiPharma
COMMITTED TO HEALTH AND WELL-BEINGWWW.ACTIPHARMA.NET
Manufactured in the USA with imported ingredients for ActiPharma, LLC San Juan, PR 00917
*Dologesic® is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63102-402-10 | 2024-08-06 | C162847 | 48780-1 | 0191ceaa-6363-198a-e063-dbdaa90aec3e | ACTIDOGESIC ® |
| 63102-402-10 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6363-198a-e063-dbdaa90aec3e | ACTIDOGESIC ® |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63102-402-10 | ACTIDOGESIC | 100 in 1 BOTTLE | TABLET | 100 | 5 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63102-402-10 | EA - Each | 63102-402 | 7639ce03-04bd-412d-bb24-439b7f9419c4 | 1 | 2017-03-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63102-402 | 63102-402-10 |
Every source-derived ingredient row is available through these pages.
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 | DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN | ACTIPHARMA, LLC | 697da3f9-9888-4d41-ba83-87ca9bf1e54b | 2025-08-18 | Warnings | 63102-402-10 63102-402 63102040210 abf1349b-a08e-4236-9b32-42a0e76e78a9 697da3f9-9888-4d41-ba83-87ca9bf1e54b |
Adverse event summaries are temporarily unavailable. Other product information remains available.