{"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: 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. Under 18 years of age: ask a doctor"],"effective_time":"20240118","id":"fb7868aa-1279-4e6a-9ab8-fd16a2d754a7","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: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache 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":{},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (500 Tablet Bottle) NDC 58602-866-40 PrimaryHealth TO OPEN: 1. PUSH DOWN 2. TURN CAP COMPARE TO Tylenol ® 8 HR Arthritis Pain Active Ingredient * DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR ARTHRITIS PAIN Acetaminophen Extended-Release Tablets USP 650 mg Pain Reliever/Fever Reducer For the Temporary Relief of Minor Arthritis Pain 500 Extended- release tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (500 Tablet Bottle)"],"purpose":["Purpose Pain reliever/fever reducer"],"set_id":"53e7813e-e621-4166-b5c9-72cca45cd4f3","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). USP Dissolution test is pending"],"version":"3","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."]}