{"active_ingredient":["Active ingredient (in each caplet) Acetaminophen 500 mg Diphenhydramine HCI 25 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged 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 and 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 take more than directed (see Overdose warning) adults and children 12 years of age and over take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours children under 12 years of age: do not use"],"effective_time":"20230302","id":"448c4930-1c5c-4eb8-8139-e7140cee7a31","inactive_ingredient":["Inactive ingredients carnauba wax*, croscarmellose sodium*, FD&C blue #1 aluminum lake,FD&C blue #2 aluminum lake, hypromellose, magnesium stearate*, microcrystalline cellulose, polyethylene glycol, polysorbate 80*, polyvinyl alcohol*, povidone K 3, pregelatinized starch, purified water, sillcon dioxide*, sodium starch glycolate*,stearic acid*, talc*, titanium dioxide *contains one or more of these ingredients"],"indications_and_usage":["Uses temporarily 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 (1-800-222-1222) right away. 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":["Principal Display Panel extra strength Pain Reliever pm acetaminophen 500 mg Pain Reliever diphenhydramine HCI 25 mg nighttime sleep-aid caplets †Compare to active ingredients in Extra Strength Tylenol® PM †This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol® PM. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Distributed by: PL Developments 200 Hicks Street, Westbury, NY 11590","Product Label WELLNESS BASICS Extra Strength Pain Reliever PM Acetaminophen 500 mg, Diphenhydramine HCI 25 mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever Nighttime sleep-aid"],"questions":["Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"9ec9e54c-0616-415c-9ecd-ebfa04acebd4","spl_product_data_elements":["Pain Reliever PM extra strength Acetaminophen Diphenhydramine HCI ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSES MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE K30 STARCH, CORN WATER SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TALC TITANIUM DIOXIDE ALUMINUM OXIDE S525;P525;G651"],"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 new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lats more than 3 days. These could be signs of a serious condition."],"storage_and_handling":["Other information store between 15-30ºC (59-86ºF) avoid high humidity and excessive heat"],"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 trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives and 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 new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lats more than 3 days. 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 (1-800-222-1222) right away. 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"]}