{"active_ingredient":["Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid"],"active_ingredient_table":["
Active ingredients (in each caplet)
Purpose
Acetaminophen 500 mg
Pain reliever
Diphenhydramine HCl 25 mg
Nighttime sleep aid
"],"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 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 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 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":"20250702","id":"38f722c5-1d77-e710-e063-6394a90ac4d2","inactive_ingredient":["Inactive ingredients brilliant blue lake, colloidal silicon dioxide, indigo carmine lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, PVP-K30, sodium starch glycolate, stearic acid, talc, titanium dioxide."],"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 and Diphenhydramine Hydrochloride"],"generic_name":["ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Bi-Mart"],"nui":["N0000000190","N0000175587"],"package_ndc":["37835-537-01","37835-537-25"],"pharm_class_epc":["Histamine-1 Receptor Antagonist [EPC]"],"pharm_class_moa":["Histamine H1 Receptor Antagonists [MoA]"],"product_ndc":["37835-537"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1092189"],"spl_id":["38f722c5-1d77-e710-e063-6394a90ac4d2"],"spl_set_id":["70084eea-1480-4c46-b849-4c779319cb74"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE"],"unii":["362O9ITL9D","8GTS82S83M"],"upc":["0071357006748","0071357008216"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL-100 Count NDC 37835-537-01 Compare to the active ingredients in Extra Strength Tylenol ® PM* EXTRA STRENGTH PAIN RELIEVER PM Acetaminophen, Diphenhydramine HCl Pain Reliever / Nighttime Sleep Aid 100 Caplets *This product is not manufactured or distributed by the owner of the registered trademark Extra Strength Tylenol ® PM. Distributed by: BI-MART Eugene, OR 97402 label","PRINCIPAL DISPLAY PANEL-250 Count NDC 37835-537-25 Compare to the active ingredients in Extra Strength Tylenol ® PM* EXTRA STRENGTH PAIN RELIEVER PM Acetaminophen, Diphenhydramine HCl Pain Reliever / Nighttime Sleep Aid 250 Caplets *This product is not manufactured or distributed by the owner of the registered trademark Extra Strength Tylenol ® PM. Distributed by: BI-MART Eugene, OR 97402 label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid"],"purpose_table":["
Active ingredients (in each caplet)
Purpose
Acetaminophen 500 mg
Pain reliever
Diphenhydramine HCl 25 mg
Nighttime sleep aid
"],"questions":["Questions? call toll free 1-844-912-4012"],"set_id":"70084eea-1480-4c46-b849-4c779319cb74","spl_product_data_elements":["Acetaminophen and Diphenhydramine Hydrochloride Acetaminophen and Diphenhydramine Hydrochloride FD&C BLUE NO. 1 SILICON DIOXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE DIPHENHYDRAMINE APM"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts 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 between 20-25°C (68-77°F) DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED"],"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 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 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 serious underlying medical illness. pain gets worse or lasts more than 10 days fever gets worse or lasts 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 (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"]}