{"active_ingredient":["Active ingredient Acetaminophen 500 mg"],"dosage_and_administration":["Directions ■ do not take more than directed (see Overdose warning) ■ adults and children 12 years and over ■ chew 2 chewable gels every 6 hours while symptoms last ■ do not take more than 6 chewable gels in 24 hours, unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor ■ children under 12 years: do not use"],"effective_time":"20260622","id":"40bd55d6-ecd7-4357-9bc6-905a8ca6cb94","inactive_ingredient":["Inactive ingredients"],"indications_and_usage":["Uses ■ temporarily relieves minor aches and pains due to ■ headache ■ the common cold ■ 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 Overdose warning : In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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":["M013"],"brand_name":["Pain Reliever"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["Orelli Inc."],"package_ndc":["87780-236-50"],"product_ndc":["87780-236"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["665056"],"spl_id":["40bd55d6-ecd7-4357-9bc6-905a8ca6cb94"],"spl_set_id":["4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"],"upc":["0359726235518"]},"package_label_principal_display_panel":["Principal Display Panel Orelli Adult Extra Strength Pain Reliever Acetaminophen 500 mg Pain Reliever Fever Reducer Cherry Flavor Aspirin Free, Ibuprofen Free For Ages 12 Years And Over Solid Chewable Gels †Compare to the active ingredient in Tylenol® Extra Strength †This product is not manufactured or distributed by Kenvue Brands LLC, distributor of Tylenol® Extra Strength.","Package label Orelli Adult Extra Strength Pain Reliever Acetaminophen 500 mg"],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions"],"set_id":"4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d","spl_product_data_elements":["Pain Reliever Acetaminophen ACETAMINOPHEN ACETAMINOPHEN ALCOHOL D&C RED NO. 33 ETHYLCELLULOSE AMMONIUM GLYCYRRHIZATE GLYCERIN GLYCYRRHIZIN MALIC ACID MALTODEXTRIN PECTIN POLYETHYLENE PROPYLENE GLYCOL WATER SUCRALOSE ANHYDROUS CITRIC ACID SUCROSE CORN SYRUP TRISODIUM CITRATE DIHYDRATE CYCLOHEXANE A"],"spl_unclassified_section":["Other information ■ each gel contains: sodium 25 mg ■ store at controlled room temperature 20-25°C (68-77°F)"],"version":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. 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 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 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. 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."]}