{"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 For Arthritis Pain Do not take more than directed. See overdose warning adults: 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 under 18 years of age: ask a doctor For Muscle Aches & Pains 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"],"effective_time":"20250224","id":"2ef14964-4fa1-9fb6-e063-6294a90aff36","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 For Arthritis Pain temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever For Muscle Aches & Pains 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. 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."],"openfda":{"application_number":["ANDA215486"],"brand_name":["Acetaminophen"],"generic_name":["ACETAMINOPHEN TABLET EXTENDED RELEASE"],"manufacturer_name":["Asclemed USA, Inc."],"original_packager_product_ndc":["49483-699"],"package_ndc":["76420-914-40","76420-914-01","76420-914-05","76420-914-26","76420-914-42","76420-914-60"],"product_ndc":["76420-914"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1148399"],"spl_id":["2ef14964-4fa1-9fb6-e063-6294a90aff36"],"spl_set_id":["4ef6bc2b-03cf-474f-bb9e-dbb5792ec197"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"other_safety_information":["Questions or comments? Call 1-877-290-4008"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501 label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer"],"set_id":"4ef6bc2b-03cf-474f-bb9e-dbb5792ec197","spl_product_data_elements":["Acetaminophen Acetaminophen tablet extended release STARCH, CORN POVIDONE K30 MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED TRIACETIN CARNAUBA WAX TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) ACETAMINOPHEN ACETAMINOPHEN White to off white 71"],"stop_use":["Stop using 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."],"storage_and_handling":["Other information store between 20-25°C (68-77°F) The FDA approved Dissolution methods differ from USP"],"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."]}