{"active_ingredient":["Acetaminophen 500 mg Diphenhydramine HCI 25 mg"],"dosage_and_administration":["Do not exceed recommended dose Adults and children 12 years of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets in 24 hours. Children under 12 years of age: Do not use this product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage."],"effective_time":"20170809","id":"58228637-c2cf-47d7-accf-fa337f2728da","inactive_ingredient":["FD and C Blue #1 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), polyvinyl alcohol, polyvinylpyrrolidone, sodium carboxymethyl starch, starch, stearic acid, talc, titanium dioxide."],"indications_and_usage":["Temporary relief of occasional headaches, minor aches, and pains accompanying sleeplessness"],"keep_out_of_reach_of_children":["Keep out of reach of Children"],"openfda":{},"package_label_principal_display_panel":["label"],"purpose":["Acetaminophen - Pain Reliever Diphenhydramine - Nighttime Sleep Aid"],"set_id":"7106c51a-f81f-4086-9e04-1f032a94aaa8","spl_product_data_elements":["PM Acetaminophen Diphenhydramine, Acetaminophen Diphenhydramine Diphenhydramine Acetaminophen Acetaminophen Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol Polyvinyl Alcohol Povidone K30 Stearic Acid Talc Titanium Dioxide FD&C BLUE NO. 1 Sky Blue Oval V15"],"version":"3","warnings":["Liver Warning: This product contains acetaminophen. Severe liver damage may occur with this product if you take: More than 2 caplets in 24 hours, which is the daily maximum amount With other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Overdose warning: Taking more than the recommended done (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms. Do not use: With other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. In Children under 12 years of age With other products containing diphenhydramine, even one used on skin Ask a doctor before use if you have: liver disease, asthma, breathing problems such as emphysema or chronic bronchitis, glaucoma, or difficulty in urinating due to an enlargement of the prostate gland. Ask a doctor or pharmacist before use if you are: taking sedatives or tranquilzers, or taking the blood thinning drug warfin When using this product: Avoid alcoholic beverages, do not drive a motor vehicle or operate machinery. This product will cause drowsiness. Stop use and ask a doctor if: Sleepiness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. Pain gets worse or last for more than 10 days Fever gets worse or lasts for more than 3 days New symptoms occur Redness or swelling is present If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children."]}