{"active_ingredient":["Active ingredient (in each softgel) Acetaminophen 325 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 the user is 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 do not give this product to children for the pain of arthritis unless directed by a doctor"],"dosage_and_administration":["Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 softgels every 4 to 6 hours while symptoms last do not take more than 10 softgels in 24 hours do not use for more than 10 days unless directed by a doctor children 6-11 years take 1 softgel every 4 to 6 hours while symptoms last do not take more than 5 softgels in 24 hours do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor"],"dosage_and_administration_table":["
adults and children 12 years and overtake 2 softgels every 4 to 6 hours while symptoms lastdo not take more than 10 softgels in 24 hoursdo not use for more than 10 days unless directed by a doctor
children 6-11 yearstake 1 softgel every 4 to 6 hours while symptoms lastdo not take more than 5 softgels in 24 hoursdo not use for more than 5 days unless directed by a doctor
children under 6 yearsask a doctor
"],"effective_time":"20241212","id":"2914c0af-16ca-97c4-e063-6294a90ae30b","inactive_ingredient":["Inactive ingredients FD&C red # 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 10 Softgel Bottle Carton VALUMEDS ™ COMPARE to the active ingredient in REGULAR STRENGTH TYLENOL®* REGULAR STRENGTH PAIN RELIEF Acetaminophen 325 mg PAIN RELIEVER/FEVER REDUCER 10 softgels Actual Size APAP"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions or comments? Call 1-888-333-9792"],"set_id":"6efe444b-dba1-4723-a37e-f6c4812a630e","spl_product_data_elements":["REGULAR STRENGTH PAIN RELIEF ACETAMINOPHEN FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN OBLONG 800"],"spl_unclassified_section":["Drug Facts","DISTRIBUTED BY SPIRIT PHARMACEUTICALS LLC. RONKONKOMA, NY 11779"],"stop_use":["Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children under 12 years 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 between 20-25°C (68-77°F)"],"version":"8","warnings":["Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 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. 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 do not give this product to children for the pain of arthritis unless directed by a doctor Ask a doctor before use if the user has liver disease Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children under 12 years 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."]}