{"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 ask a doctor. Other information store between 20-25°C (68-77°F) The FDA approved Dissolution methods differ from USP do not use if carton is opened. Do not use if foil inner seal is broken or missing"],"dosage_and_administration_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\"><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\">adults and children 12 years and over </td><td styleCode=\"Rrule\" valign=\"middle\"><list listType=\"unordered\" styleCode=\"disc\"><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 styleCode=\"Lrule Rrule\" valign=\"middle\"> children under 12 years</td><td styleCode=\"Rrule\" valign=\"middle\"><list listType=\"unordered\" styleCode=\"disc\"><item> ask a doctor.</item></list></td></tr></tbody></table>"],"effective_time":"20231017","id":"9e2c09cd-1bd4-4a86-8911-ba904d8a76cb","inactive_ingredient":["Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin Questions or comments ? Call at 1-877-376-4271 Mon-Fri 9.00am - 6.00pm EST"],"indications_and_usage":["Uses Acetaminophen Extended-Release Tablets USP, 650 mg - 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. Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain 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 Extended-Release Tablets, 650 mg"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["MARKSANS PHARMA LIMITED"],"package_ndc":["25000-071-02","25000-071-08","25000-071-10","25000-071-11","25000-071-45","25000-108-02","25000-108-08"],"product_ndc":["25000-071","25000-108"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1148399"],"spl_id":["9e2c09cd-1bd4-4a86-8911-ba904d8a76cb"],"spl_set_id":["d973a910-5fe0-4a85-884d-2c3987836691"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"],"upc":["0325000071110","0325000108021","0325000071028","0325000071103","0325000108083","0325000071080","0325000071455"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 25000-071-02 Acetaminophen Extended-Release Tablets USP, 650 mg - Arthritis Pain 24 count carton label NDC 25000-071-02 Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain 24 count bottle label NDC 25000-071-08 Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain 100 count carton label NDC 25000-071-08 Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain 100 count bottle label NDC 25000-071-10 Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain 225 count carton label NDC 25000-071-10 Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain 225 count bottle label NDC 25000-071-11 Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain 290 count carton label NDC 25000-071-11 Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain 290 count bottle label NDC 25000-071-45 Acetaminophen Extended-Release Tablets USP, 650 mg- Arthritis Pain 400 count bottle label NDC 25000-108-02 Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain 24 count carton label NDC 25000-108-02 Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain 24 count bottle label NDC 25000-108-08 Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain 100 count carton label NDC 25000-108-08 Acetaminophen Extended-Release Tablets USP, 650 mg - Muscle Aches and Pain 100 count bottle label aceta-24s-carton aceta-24s-label aceta-100s-carton aceta-100s-label aceta-225s-carton aceta-225s-label aceta-290s-carton aceta-290s-label aceta-400s-label aceta-musclepain-24s-carton aceta-musclepain-24s-label aceta-musclepain-100s-carton aceta-muscle-100s-label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer"],"set_id":"d973a910-5fe0-4a85-884d-2c3987836691","spl_product_data_elements":["Acetaminophen Extended-Release Tablets, 650 mg Acetaminophen ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POVIDONE K30 MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED TRIACETIN CARNAUBA WAX TITANIUM DIOXIDE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) White to off white 71 Acetaminophen Extended-Release Tablets, 650 mg Acetaminophen ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN POVIDONE K30 MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED TRIACETIN CARNAUBA WAX TITANIUM DIOXIDE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) white to off white 71"],"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":"5","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."]}