{"active_ingredient":["Drug Facts Active ingredients (in each captab) Acetaminophen 500 mg Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma"],"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 product containing diphenhydramine, even one used on skin in children under 12 years of age with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients"],"dosage_and_administration":["Directions do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 captabs at bedtime. Do not take more than 2 captabs of this product in 24 hours children under 12 years: do not use"],"effective_time":"20190523","id":"89952f8d-a0fa-d966-e053-2a95a90a15ba","inactive_ingredient":["croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin"],"indications_and_usage":["Uses 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."],"openfda":{},"other_safety_information":["Other information store at room temperature"],"overdosage":["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."],"package_label_principal_display_panel":["COMPARE TO THE ACTIVE INGREDIENTS IN EXTRA STRENGTH TYLENOL ® PM* Rugby ® NDC 0536-1173-06 See New Warnings Information & Directions Acetaminophen 500 mg & Diphenhydramine HCI 25 mg Pain Rekiever/ Sleep Aid 50 Caplets 0752-rugby-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? Call (800) 645-2158"],"set_id":"786eee58-3827-9cb3-e053-2a91aa0a4140","spl_product_data_elements":["Acetaminophen, Diphenhydramine Hydrochloride Acetaminophen, Diphenhydramine Hydrochloride SODIUM STARCH GLYCOLATE TYPE A POTATO HYPROMELLOSES MAGNESIUM STEARATE SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE CROSCARMELLOSE SODIUM CROSCARMELLOSE POVIDONE K30 TRIACETIN D&C YELLOW NO. 10 LIGHT MINERAL OIL STARCH, CORN TALC ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 CPC752"],"spl_unclassified_section":["Do not use if imprinted safety seal under cap is broken or missing Distributed by: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 www.rugbylaboratories.com *Rugby Laboratories is not affiliated with the owner of the registered trademark Tylenol®."],"stop_use":["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 more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition."],"version":"2","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 product containing diphenhydramine, even one used on skin in children under 12 years of age with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 difficulty in urination due to enlargement of the prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery 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 more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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 drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery"]}