{"active_ingredient":["Drug Facts Active ingredients (in each caplet) 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 ■ difculty 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 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":"20260529","id":"52fac64b-8e53-d7b7-e063-6294a90a3b71","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 and 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":{"application_number":["M013"],"brand_name":["Acetaminophen PM"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Major Pharmaceuticals"],"package_ndc":["0904-6731-51"],"product_ndc":["0904-6731"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1092189"],"spl_id":["52fac64b-8e53-d7b7-e063-6294a90a3b71"],"spl_set_id":["786dbcd5-f5c2-4491-e053-2991aa0a3437"],"substance_name":["DIPHENHYDRAMINE HYDROCHLORIDE","ACETAMINOPHEN"],"unii":["TC2D6JAD40","362O9ITL9D"]},"other_safety_information":["Other information store in a dry place at 15° – 30°C (59° – 86°F)."],"overdosage":["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."],"package_label_principal_display_panel":["NDC 0904-6731-51 Compare to active ingredient oin Extra Strength TYLENOL® PM* MAJOR® Extra Strength Acetaminophen PM Acetaminophen and Diphenhydramine HCl 500mg/25mg Pain Reliever/ Nighttime Sleep Aid 50 Caplets Major Label"],"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 (800) 231-4670"],"set_id":"786dbcd5-f5c2-4491-e053-2991aa0a3437","spl_product_data_elements":["Acetaminophen PM Acetaminophen, Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE D&C YELLOW NO. 10 ACETAMINOPHEN ACETAMINOPHEN LIGHT MINERAL OIL POVIDONE K30 TRIACETIN HYPROMELLOSES STARCH, CORN CROSCARMELLOSE SODIUM CROSCARMELLOSE FD&C BLUE NO. 1 MAGNESIUM STEARATE SILICON DIOXIDE STEARIC ACID SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE CPC752"],"spl_unclassified_section":["KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol®. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Questions or comments? Call (800) 616-2471 www.majorpharmaceuticals.com Rev. 10/23 M-29 Re-Order No. 700920"],"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 lasts more than 3 days These could be signs of a serious condition."],"version":"6","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 ■ difculty 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 ■ avoid alcoholic beverages ■ do not drive a motor vehicle or operate machinery ■ drowsiness will occur 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 lasts 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 ■ avoid alcoholic beverages ■ do not drive a motor vehicle or operate machinery ■ drowsiness will occur"]}