{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen , 500 mg Dexbrompheniramine Maleate, 1 mg"],"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.
"],"effective_time":"20250818","id":"abf1349b-a08e-4236-9b32-42a0e76e78a9","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"],"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."],"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."],"openfda":{"application_number":["M012"],"brand_name":["ACTIDOGESIC"],"generic_name":["DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["ACTIPHARMA, LLC"],"package_ndc":["63102-402-10"],"product_ndc":["63102-402"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1798453"],"spl_id":["abf1349b-a08e-4236-9b32-42a0e76e78a9"],"spl_set_id":["697da3f9-9888-4d41-ba83-87ca9bf1e54b"],"substance_name":["DEXBROMPHENIRAMINE MALEATE","ACETAMINOPHEN"],"unii":["BPA9UT29BS","362O9ITL9D"],"upc":["0363102402104"]},"package_label_principal_display_panel":["Packaging ACTIDOGESIC"],"purpose":["Purpose Pain reliever/Fever reducer Antihistamine"],"questions":["Questions or Comments? Call weekdays from 8:00 AM - 4:00 PM, AST at 1-787-608-0882"],"set_id":"697da3f9-9888-4d41-ba83-87ca9bf1e54b","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."],"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"],"version":"5","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."]}