{"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 children12 years of age and olderTake 2 caplets every 4 to 6 hours as needed,do not exceed 8 caplets in 24 hours, or asdirected by a doctor, do not use for more than10 days unless directed by a doctor.
Children under 12 years of ageDo not use.
"],"effective_time":"20250709","id":"d024a896-b400-4d33-a6aa-9643f823d4e2","inactive_ingredient":["Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, sodium starch glycolate."],"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 and 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 DF"],"generic_name":["ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE"],"is_original_packager":[true],"manufacturer_name":["ACTIPHARMA, LLC"],"package_ndc":["63102-403-10"],"product_ndc":["63102-403"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1798453"],"spl_id":["d024a896-b400-4d33-a6aa-9643f823d4e2"],"spl_set_id":["ff8e2565-bce3-4c06-a416-6e8f369f057f"],"substance_name":["ACETAMINOPHEN","DEXBROMPHENIRAMINE MALEATE"],"unii":["362O9ITL9D","BPA9UT29BS"],"upc":["0363102403101"]},"package_label_principal_display_panel":["Packaging ACTIDOGESIC DF"],"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":"ff8e2565-bce3-4c06-a416-6e8f369f057f","spl_product_data_elements":["ACTIDOGESIC DF Acetaminophen, Dexbrompheniramine Maleate ACETAMINOPHEN ACETAMINOPHEN DEXBROMPHENIRAMINE MALEATE DEXBROMPHENIRAMINE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A A403"],"spl_unclassified_section":["Drug Facts","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"],"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. 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."]}