{"active_ingredient":["Active ingredient (in each capsule) Acetaminophen 500 mg"],"ask_doctor":["Ask a doctor before use if the user has 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 have ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions Do not take more than directed (see Overdose warning ) Adults and children 12 years of age and over take 2 softgels every 4 to 6 hours while symptoms last do not take more than 6 softgels in 24 hours unless directed by a doctor do not take more than 10 days unless diredted by doctor Children 12 years of age ask a doctor"],"dosage_and_administration_table":["
Adults and children 12 years of age and overtake 2 softgels every 4 to 6 hours while symptoms lastdo not take more than 6 softgels in 24 hours unless directed by a doctordo not take more than 10 days unless diredted by doctor
Children 12 years of ageask a doctor
"],"effective_time":"20241125","id":"27c7638c-508b-3868-e063-6394a90af73b","inactive_ingredient":["Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China"],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M013"],"brand_name":["Pain Relief Extra Strength"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["Humanwell PuraCap Pharmaceutical (Wuhan), Ltd."],"package_ndc":["53345-019-01","53345-019-02"],"product_ndc":["53345-019"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198439"],"spl_id":["27c7638c-508b-3868-e063-6394a90af73b"],"spl_set_id":["5c42dd28-820c-4cc5-9016-11ad5e580616"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"]},"overdosage":["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."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Shipping Label ACETAMINOPHEN CAPSULES, 500 mg Quantity : 3000 Capsules NDC. No : 53345-019-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : \"FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING\" Shipping Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/ fever reducer"],"set_id":"5c42dd28-820c-4cc5-9016-11ad5e580616","spl_product_data_elements":["Pain Relief Extra Strength ACETAMINOPHEN FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL ACETAMINOPHEN ACETAMINOPHEN oblong PC24"],"spl_unclassified_section":["Drug Facts","ACETAMINOPHEN CAPSULES, 500 mg Quantity : 3000 Capsules NDC. No : 53345-019-01 IMP ORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : \"FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING\" Shipping Label"],"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."],"storage_and_handling":["Other information store at room temperature 15°-30°C (59°-86°F)"],"version":"5","warnings":["Warnings Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 softgels (3,000 mg) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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 have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if the user has liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. 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. 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."]}