{"active_ingredient":["Active Ingredient Acetaminophen 325 mg and Diphenhydramine HCl 12.5 mg"],"dosage_and_administration":["Directions • adults and children 12 years & over: take 2 tablets every 4 hours, but not more than 8 tablets in 24 hours • children under 12 years: do not use"],"effective_time":"20190911","id":"9586f9c0-b5df-4040-978b-84ff2ddc1398","inactive_ingredient":["Inactive Ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 (al-lake), hypromellose, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, pregelatinized starch, purified water, stearic acid, titanium dioxide."],"indications_and_usage":["Uses Temporarily reduces fever and relieves minor aches and pain caused by • common cold • headache • toothache • muscular aches • backache • arthritis • flu • premenstrual and menstrual cramps"],"keep_out_of_reach_of_children":["Other Information Store at room temperature 15°-30°C (59°-86°F)"],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL • TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 100 Tablets NDC 0536-3605-01 Rugby Acetaminophen 325 mg / Diphenhydramine HCl 12.5 mg Pain Reliever, Fever Reducer, Antihistamine bottle label"],"purpose":["Purposes Pain Reliever/Fever Reducer Antihistamine"],"questions":["QUESTIONS Call 1-800-645-2158, 9 am – 5 pm ET, Monday – Friday."],"set_id":"e49e69ae-3d87-47e4-b486-cfcc8798e991","spl_product_data_elements":["Acetaminophen and Diphenhydramine HCl Acetagesic DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ACETAMINOPHEN ACETAMINOPHEN SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE MINERAL OIL POLYETHYLENE GLYCOL 450 POVIDONE, UNSPECIFIED STARCH, CORN WATER STEARIC ACID TITANIUM DIOXIDE peach AP;126"],"version":"3","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult or child 12 years and older takes more than 8 tablets in less than 24 hours which is the maximum daily amount • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks everyday 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. • with any other drug containing diphenhydramine, even one used on skin Ask a doctor before use if the user has • liver disease • glaucoma • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if the user is. • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • you may get very drowsy • avoid alcoholic drinks • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children 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 • redness or swelling is present • any new symptoms appear If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."]}