{"active_ingredient":["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 ue 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":"20260204","id":"4a0449b1-7dd9-f323-e063-6294a90ac587","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin"],"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":{"application_number":["ANDA207229"],"brand_name":["Acetaminophen"],"generic_name":["ACETAMINOPHEN"],"manufacturer_name":["American Health Packaging"],"original_packager_product_ndc":["68001-495"],"package_ndc":["60687-924-11","60687-924-21"],"product_ndc":["60687-924"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1148399"],"spl_id":["4a0449b1-7dd9-f323-e063-6294a90ac587"],"spl_set_id":["88e5345a-f240-473c-b329-2b0aa5f081f9"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"package_label_principal_display_panel":["Principal Display Panel – Carton – 650 mg NDC 60687- 924 -21 Acetaminophen Extended-release Tablets USP Pain Reliever/Fever Reducer 650 mg 30 Tablets (3 x 10) DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN. Drug Facts Active Ingredient Purpose (in each caplet) Acetaminophen USP, 650 mg.................Pain reliever/fever reducer Uses See package insert for complete Drug Facts information. 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. See package insert for additional Drug Facts warnings. Directions • do not take more than directed, see package insert for overdose warning and complete Drug Facts information. Other Information • store at 20° to 25°C (68° to 77°F). Avoid excessive heat 40°C (104°F). • FOR YOUR PROTECTION: Do not use product if blister is torn or broken. •USP Dissolution test is pending Contains No Aspirin The drug product contained in this package is from NDC # 68001-495, BluePoint Laboratories Distributed by: American Health Packaging Columbus, OH 43217 792421 0492421/0825 650 mg Acetaminophen ER Tablets Carton.jpg","Principal Display Panel – Blister – 650 mg Acetaminophen Extended-Release Tablet USP Pain Reliever/ Fever Reducer 650 mg 650 mg Acetaminophen ER Tablet Blister.jpg"],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions or comments? about the drug product, call Aurobindo Pharma USA at 1-855-274-4122 about the packaging or labeling, call American Health Packaging at 1-800-707-4621 Contains No Aspirin"],"set_id":"88e5345a-f240-473c-b329-2b0aa5f081f9","spl_product_data_elements":["Acetaminophen Acetaminophen STARCH, CORN TITANIUM DIOXIDE TRIACETIN SILICON DIOXIDE POVIDONE, UNSPECIFIED HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE B POTATO HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE ACETAMINOPHEN ACETAMINOPHEN (White to Off-White) (Caplet) I;06"],"spl_unclassified_section":["Drug Facts","PACKAGING INFORMATION American Health Packaging unit dose blisters contain drug product from BluePoint Laboratories as follows: (650 mg / 30 UD) NDC 60687-924-21 packaged from NDC 68001-495 Distributed by: American Health Packaging Columbus, OH 43217 8492421/0825F"],"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 20º to 25ºC (68º to 77ºF). Avoid excessive heat 40ºC (104ºF) do not use if carton is opened or foil inner seal is broken USP Dissolution test is pending"],"version":"1","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."]}