{"active_ingredient":["Active ingredients (in each tablet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg (equiv. to Diphenhydramine citrate 38 mg)"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers"],"do_not_use":["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"],"dosage_and_administration":["Directions do not use more than directed (see overdose warning) adults and children 12 years of age and over: take 2 tablets at bedtime, if needed, or as directed by a doctor do not take more than 2 tablets of this product in 24 hours children under 12 years of age: do not use"],"effective_time":"20200506","id":"a4fdb7d5-82b9-44b1-e053-2995a90a3b3e","inactive_ingredient":["Inactive ingredients carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide"],"indications_and_usage":["Uses for the temporary relief of occasional headaches and minor aches and pains 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":["DRUG: leader headache pm formula GENERIC: Acetaminophen, Diphenhydramine HCl DOSAGE: TABLET, FILM COATED ADMINSTRATION: ORAL NDC: 70518-0824-0 COLOR: blue SHAPE: ROUND SCORE: No score SIZE: 11 mm IMPRINT: L355;PM PACKAGING: 50 in 1 BOTTLE ACTIVE INGREDIENT(S): ACETAMINOPHEN 500mg in 1 DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 1 INACTIVE INGREDIENT(S): CARNAUBA WAX POLYSORBATE 80 POLYETHYLENE GLYCOLS POVIDONE STEARIC ACID CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE HYPROMELLOSES MAGNESIUM STEARATE TITANIUM DIOXIDE Remedy_Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever Nighttime sleep-aid"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"92790a4e-7d75-459f-af6f-32bd7da82f25","spl_product_data_elements":["leader headache pm formula Acetaminophen, Diphenhydramine HCl CARNAUBA WAX CROSPOVIDONE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 POVIDONE STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE shallow convex L355;PM"],"stop_use":["Stop use and ask a doctor if sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition."],"storage_and_handling":["Other information store at 20-25°C (68-77°F)"],"version":"2","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 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 you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product avoid alcoholic drinks drowsiness may occur be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days redness or swelling is present new symptoms occur 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 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."],"when_using":["When using this product avoid alcoholic drinks drowsiness may occur be careful when driving a motor vehicle or operating machinery"]}