{"active_ingredient":["Active Ingredients Acetaminophen 500 mg Diphenhydramine HCI 25 mg"],"dosage_and_administration":["Directions • do not take more than directed (see overdose warning) • adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. • children under 12 years: do not use"],"effective_time":"20241128","id":"27fdd9bd-5587-8ced-e063-6394a90a3c63","inactive_ingredient":["Inactive ingredients cellulose, croscarmellose sodium, FD&C blue #1 lake, FD&C blue #2 lake, hypromellose, magnesium stearate, PEG, polyvinyl alcohol, povidone, purified water, silicon dioxide, sodium starch glycolate, starch, talc, titanium dioxide"],"indications_and_usage":["Uses for the temporary relief of occasional headaches and minor ache and pains along with accompanying sleeplessness"],"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 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."],"openfda":{},"package_label_principal_display_panel":["package Label 1"],"purpose":["Purposes Pain Reliever Sleep aid"],"questions":["Questions or comments? 1-800-540-3765"],"set_id":"e5450e02-b2f2-aaf9-e053-2995a90a4c30","spl_product_data_elements":["Extra Strength Night Time Pain Medicine Acetaminophen, Diphenhydramine HCl TALC POLYVINYL ALCOHOL, UNSPECIFIED HYPROMELLOSES POVIDONE FD&C BLUE NO. 1 CROSCARMELLOSE SODIUM CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED FD&C BLUE NO. 2 TITANIUM DIOXIDE SILICON DIOXIDE STARCH, CORN ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE MAGNESIUM STEARATE WATER SODIUM STARCH GLYCOLATE TYPE A CORN P525"],"storage_and_handling":["Other information • store at controlled room temperature 20-25 °C (68-77° F)"],"version":"3","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. • with any other product containing diphenhydramine, even one used on skin • in children under 12 years of age • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin • sedatives or tranquilizers When using this product • drowsiness will occur • do not drive a motor vehicle or operate machinery after use • avoid alcoholic drinks Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • pain gets worse or lasts for more that 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present.These may 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."]}