{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "ACTIDOGESIC Dexbrompheniramine maleate, acetaminophen DEXBROMPHENIRAMINE MALEATE DEXBROMPHENIRAMINE ACETAMINOPHEN ACETAMINOPHEN FD&C RED NO. 40 ALUMINUM LAKE FD&C YELLOW NO. 6 ALUMINUM LAKE GLYCERYL MONO- AND DICAPRYLOCAPRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYVINYL ALCOHOL, UNSPECIFIED POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW) SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID TALC TITANIUM DIOXIDE A402" ], "spl_unclassified_section": [ "Drug Facts", "• ANALGESIC • FEVER REDUCER • ANTIHISTAMINE Contains the same active ingredients as Dologesic ® SUGAR FREE ActiPharma COMMITTED TO HEALTH AND WELL-BEING WWW.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." ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen , 500 mg Dexbrompheniramine Maleate, 1 mg" ], "purpose": [ "Purpose Pain reliever/Fever reducer Antihistamine" ], "indications_and_usage": [ "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, watery eyes due to hay fever." ], "warnings": [ "Warnings 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." ], "keep_out_of_reach_of_children": [ "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." ], "dosage_and_administration": [ "Directions • 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." ], "dosage_and_administration_table": [ "
Adults and children 12 years of age and olderTake 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.
" ], "storage_and_handling": [ "Other information • 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" ], "inactive_ingredient": [ "Inactive ingredients: 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" ], "questions": [ "Questions or Comments? Call weekdays from 8:00 AM - 4:00 PM, AST at 1-787-608-0882" ], "package_label_principal_display_panel": [ "Packaging ACTIDOGESIC" ], "set_id": "697da3f9-9888-4d41-ba83-87ca9bf1e54b", "id": "abf1349b-a08e-4236-9b32-42a0e76e78a9", "effective_time": "20250818", "version": "5", "openfda": { "application_number": [ "M012" ], "brand_name": [ "ACTIDOGESIC" ], "generic_name": [ "DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN" ], "manufacturer_name": [ "ACTIPHARMA, LLC" ], "product_ndc": [ "63102-402" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXBROMPHENIRAMINE MALEATE" ], "rxcui": [ "1798453" ], "spl_id": [ "abf1349b-a08e-4236-9b32-42a0e76e78a9" ], "spl_set_id": [ "697da3f9-9888-4d41-ba83-87ca9bf1e54b" ], "package_ndc": [ "63102-402-10" ], "is_original_packager": [ true ], "upc": [ "0363102402104" ], "unii": [ "362O9ITL9D", "BPA9UT29BS" ] } } ] }