{"active_ingredient":["Active ingredient (in each caplet) Acetaminophen 650 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are 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 you are allergic to acetaminophen or any of the inactive ingredients in this product"],"dosage_and_administration":["Directions Do not take more than directed. See overdose warning adults and children 12 years and over take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split, or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor children under 12 years do not use"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>adults and children 12 years and over</td><td><list listType=\"unordered\"><item>take 2 caplets every 8 hours with water</item><item>swallow whole; do not crush, chew, split, or dissolve</item><item>do not take more than 6 caplets in 24 hours</item><item>do not use for more than 10 days unless directed by a doctor</item></list></td></tr><tr><td>children under 12 years</td><td><list listType=\"unordered\"><item>do not use</item></list></td></tr></tbody></table>"],"effective_time":"20250603","id":"36a62f0b-6801-9ff7-e063-6394a90aca7d","inactive_ingredient":["Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin"],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["ANDA215486"],"brand_name":["8HR Muscle Aches and Pain Relief"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["LEADER/ Cardinal Health 110, Inc."],"package_ndc":["70000-0734-1"],"product_ndc":["70000-0734"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1148399"],"spl_id":["36a62f0b-6801-9ff7-e063-6394a90aca7d"],"spl_set_id":["331f4bd1-1303-cc48-e063-6394a90a74d3"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"other_safety_information":["Other information store between 20-25ºC (68-77ºF) The FDA approved dissolution methods differ from USP"],"overdosage":["Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["lc-apap-mp-label-100s lc-apap-mp-ifc-100s"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions or comments? Call 1-800-632-6900"],"set_id":"331f4bd1-1303-cc48-e063-6394a90a74d3","spl_product_data_elements":["8HR Muscle Aches and Pain Relief Acetaminophen MAGNESIUM STEARATE CARNAUBA WAX MICROCRYSTALLINE CELLULOSE POVIDONE ACETAMINOPHEN ACETAMINOPHEN TRIACETIN SODIUM STARCH GLYCOLATE TYPE A STARCH, CORN HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE (White to off white) (Capsule-shaped tablet) 71"],"spl_unclassified_section":["Drug Facts Drug Facts"],"stop_use":["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 symptoms occur redness or swelling is present These could be signs of a serious condition."],"version":"2","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets 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 If a skin reaction occurs, stop use and seek medical help right away."]}