{"active_ingredient":["Drug Facts Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg"],"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. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin"],"dosage_and_administration":["Directions do not take more than directed (see overdose warning). adults and children 12 years and over take 2 tablets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 tablets 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 cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"100%\"><colgroup><col width=\"50%\"/><col width=\"50%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults and children 12 years and over </td><td styleCode=\"Rrule\" valign=\"top\"><list listType=\"unordered\" styleCode=\"disc\"><item>take 2 tablets every 8 hours with water </item><item>swallow whole; do not crush, chew, split or dissolve</item><item>do not take more than 6 tablets in 24 hours</item><item>do not use for more than 10 days unless directed by a doctor.</item></list></td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"top\">children under 12 years </td><td styleCode=\"Rrule\" valign=\"top\"><list listType=\"unordered\" styleCode=\"disc\"><item>do not use</item></list></td></tr></tbody></table>"],"effective_time":"20240124","id":"144490f4-f2a5-4c6d-abf2-5e7ee65d66d7","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin Questions or comments? call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009"],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramp 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":["ANDA207229"],"brand_name":["Acetaminophen"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"package_ndc":["58602-873-36","58602-873-07","58602-873-14","58602-873-21","58602-873-29","58602-873-34","58602-873-35","58602-873-67","58602-873-76","58602-873-40","58602-873-41","58602-873-94","58602-873-44"],"product_ndc":["58602-873"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1148399"],"spl_id":["144490f4-f2a5-4c6d-abf2-5e7ee65d66d7"],"spl_set_id":["f076fd33-9eaf-49b9-b0ee-6a349567c5ff"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablet Bottle) AUROHEALTH TO OPEN: 1. PUSH DOWN NDC 58602-873-36 2. TURN CAP DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR MUSCLE ACHES & PAIN Acetaminophen Extended-Release Tablets USP 650 mg Pain Reliever/Fever Reducer For up to 8 Hours Relief of Minor Muscle Aches & Pain 250 Extended-release tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablet Bottle)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablets Container Carton) AUROHEALTH NDC 58602-873-36 DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR MUSCLE ACHES & PAIN Acetaminophen Extended-Release Tablets USP 650 mg Pain Reliever/Fever Reducer For Up to 8 Hours Relief of Minor Muscle Aches & Pain 250 Extended-release tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablets Container Carton)"],"purpose":["Purpose Pain reliever/fever reducer"],"set_id":"f076fd33-9eaf-49b9-b0ee-6a349567c5ff","spl_product_data_elements":["Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN SILICON DIOXIDE HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED STARCH, CORN SODIUM STARCH GLYCOLATE TYPE B POTATO TITANIUM DIOXIDE TRIACETIN White to Off-White Caplet I;06"],"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. If pregnant or breast-feeding, ask a health professional before use."],"storage_and_handling":["Other information store at 20 o to 25 o C (68 o to 77 o F). Avoid excessive heat 40 o C (104 o F). do not use if carton is opened or foil inner seal is broken Meets USP dissolution test 3"],"version":"4","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 tablets 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."]}