{"active_ingredient":["Active ingredient & Purposes Active ingredient (in each packet) Purposes Acetaminophen 500 mg Pain reliever/ fever reducer"],"active_ingredient_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredient (in each packet)</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purposes</content></content></td></tr><tr><td><content styleCode=\"bold\">Acetaminophen 500 mg</content></td><td>Pain reliever/ fever reducer</td></tr></tbody></table>"],"ask_doctor":["Ask a doctor before use if the user has liver disease is a child with pain from arthritis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin"],"do_not_use":["Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if allergic to acetaminophen or any other of the inactive ingredients in this product"],"dosage_and_administration":["Directions do not take more than directed Age Dose adults and children 12 years of age and over take one (1) packet, every 4 hours. Do not exceed; adults 8 packets or children 5 packets in 24 hours children under 12 years of age do not use"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"bold\">Age</content></td><td><content styleCode=\"bold\">Dose</content></td></tr><tr><td>adults and children 12 years of age and over</td><td>take one (1) packet, every 4 hours. Do not exceed; <content styleCode=\"bold\">adults 8 packets </content>or <content styleCode=\"bold\">children 5 packets</content> in 24 hours </td></tr><tr><td>children under 12 years of age</td><td><content styleCode=\"bold\">do not use</content></td></tr></tbody></table>"],"effective_time":"20251222","id":"468fc0a7-2a13-5c91-e063-6294a90af9a2","inactive_ingredient":["Inactive ingredients chamomile lemon flavor, citric acid monohydrate, fructose, povidone k30, silicon dioxide, sodium bicarbonate, sucralose, water"],"indications_and_usage":["Uses For the temporary relief of minor aches and pains associated with sore throat headache the common cold/ flu muscular aches backache minor pain from arthritis and to reduce fever"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of an accidental overdose, get medical help or contact a Poison Control Center right away. 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":["M013"],"brand_name":["Vitapirena"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"package_ndc":["55758-012-05"],"product_ndc":["55758-012"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2668206"],"spl_id":["468fc0a7-2a13-5c91-e063-6294a90af9a2"],"spl_set_id":["0547bc1f-d000-f5a6-e063-6294a90ac73d"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"other_safety_information":["Other information each 5g packet contains: 1 78 mg sodium store at room temprature 77-86° F (25-30° C)"],"package_label_principal_display_panel":["Principal Display Panel PDP Vitapirena CL"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use."],"purpose":["Active ingredient (in each packet) Purposes Acetaminophen 500 mg Pain reliever/ fever reducer"],"purpose_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredient (in each packet)</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purposes</content></content></td></tr><tr><td><content styleCode=\"bold\">Acetaminophen 500 mg</content></td><td>Pain reliever/ fever reducer</td></tr></tbody></table>"],"questions":["Questions? +1-866--359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com"],"set_id":"0547bc1f-d000-f5a6-e063-6294a90ac73d","spl_product_data_elements":["Vitapirena ACETAMINOPHEN ANHYDROUS CITRIC ACID SODIUM BICARBONATE POVIDONE K30 WATER FRUCTOSE SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN SILICON DIOXIDE +Chamomile"],"spl_unclassified_section":["Drug Facts","Distributed by: PHARMADEL LLC. New Castle, DE 19720"],"stop_use":["Stop use and ask a doctor if adult’s pain gets worse or lasts more than 10 days child’s pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear"],"version":"3","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult takes more than 8 packets in 24 hours, which is the maximum daily amount for this product child takes more than 5 packets in 24 hours with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if allergic to acetaminophen or any other of the inactive ingredients in this product Ask a doctor before use if the user has liver disease is a child with pain from arthritis Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin Stop use and ask a doctor if adult’s pain gets worse or lasts more than 10 days child’s pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."]}