{"active_ingredient":["Active ingredient Acetaminophen 500 mg"],"dosage_and_administration":["Directions Do not take more than directed (see overdose warnings) Adults and children 12 years and over Take 2 gelcaps every 4-6 hours, as needed. Do not take more than 8 gelcaps in 24 hours Children under 12 years Do not use"],"dosage_and_administration_table":["<table border=\"1\" width=\"75%\"><tbody><tr><td>Adults and children 12 years and over</td><td><list listType=\"unordered\"><item>Take 2 gelcaps every 4-6 hours, as needed.</item><item>Do not take more than 8 gelcaps in 24 hours</item></list></td></tr><tr><td>Children under 12 years</td><td>Do not use</td></tr></tbody></table>"],"effective_time":"20241128","id":"27fdfee0-44d8-1f36-e063-6394a90a68a4","inactive_ingredient":["Inactive Ingredients croscarmellose sodium, D&C Red #33, FD&C Blue #1, FD&C Red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide, PEG, povidone, propylene glycol, shellac glaze, starch, stearic acid, titanium dioxide."],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: - headache - muscular aches - backache - arthritis - the common cold - toothache - menstrual cramps temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["package label NDC 68016-029-47 Compare to active ingredient in Extra Strength Tylenol Rapid Release Gels* Extra Strength PAIN RELIEF ACETAMINOPHEN Rapid Release Pain Reliever/ Fever Reducer Gelcaps 400 Gelcaps 500 mg each 251 label"],"purpose":["Purpose Pain Reliever/Fever Reducer"],"set_id":"05e11584-1876-0207-e054-00144ff88e88","spl_product_data_elements":["Extra Strength Pain Relief Acetaminophen CROSCARMELLOSE SODIUM D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL STARCH, CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN TITANIUM DIOXIDE FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES FERRIC OXIDE RED SHELLAC Gelcap L;5 with blue and a gray band"],"storage_and_handling":["Other Information TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. store at controlled room temperature 20⁰C-25⁰C (68⁰F-77⁰F) avoid high humidity Inactive Ingredients croscarmellose sodium, D&C Red #33, FD&C Blue #1, FD&C Red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide, PEG, povidone, propylene glycol, shellac glaze, starch, stearic acid, titanium dioxide."],"version":"6","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 gelcaps 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 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. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are t aking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptom 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. Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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."]}