{"active_ingredient":["Active Ingrdient (in each captab)"],"dosage_and_administration":["Directions adults and children 12 years or over: • take 2 captabs at bedtine if needed • do not take more than directed childrens under 12 years do not use"],"effective_time":"20190909","id":"f40489a9-8067-4e79-8b25-ce9683917630","inactive_ingredient":["Inactive Ingredients Croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, pregelatinized corn starch, silicon dioxide, stearic acid, titanium dioxide."],"indications_and_usage":["Uses Temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness."],"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 50 Captabs Bottle Carton NDC 0536-3479-06 Rugby ACETAMINOPHEN 500 mg / Diphenhydramine HCl 25 mg Pain Reliever / Sleep Aid 50 Captabs bottle label"],"purpose":["PURPOSE Pain Reliever/Sleep Aid"],"questions":["QUESTIONS Call 1-800-645-2158, 9 am – 5 pm ET, Monday – Friday."],"set_id":"108a2bc2-7960-4be3-8671-577a4ed1d1bd","spl_product_data_elements":["Acetaminophen and Diphenhydramine HCl Acetaminophen and Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POVIDONE, UNSPECIFIED STARCH, CORN SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE light blue AP;133"],"version":"3","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 captabs in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 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 • in children under 12 years of age Ask a doctor before use if you have • liver disease • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are. • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • marked drowsiness will occur • avoid alcoholic drinks • alcohol, sedatives and tranquilizers may increase drowsiness • do not drive motor vehicle or operate machinery 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 • sleeplessness lasts more than 2 weeks. Insomnia may be a sign of serious underlying medical illness. If pregnant or breast feeding, ask a health professional before use. Keep out of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms."]}