{"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. Trouble urinating due to an enlarged prostate gland. Glaucoma."],"ask_doctor_or_pharmacist":["Ask your doctor or pharmacist before use if you are Taking the blood thinning drug warfarin Taking sedative or tranquilizers."],"do_not_use":["Do not use With any other drug containing acetaminophen (prescription or not prescription). 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 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"],"dosage_and_administration_table":["<table border=\"1\" width=\"100%\"><tbody><tr><td>Adults and children 12 years and over</td><td><list listType=\"unordered\"><item>Take 2 caplets at bedtime.</item><item>Do not take more than 2 caplets of this product in 24 hours.</item></list></td></tr><tr><td>Children under 12 years</td><td>Do not use</td></tr></tbody></table>"],"effective_time":"20250811","id":"3c19ad99-6e10-3116-e063-6394a90a914c","inactive_ingredient":["Inactive ingredients FD&C Blue No. 1, FD&C Blue No. 2, Hypromellose, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol, Povidone, Pregelatinized starch, Purified water, Stearic Acid, Titanium dioxide."],"indications_and_usage":["Uses Temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness.","Directions ​Do not use more than directed (see overdose warning). Directions 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"],"indications_and_usage_table":["<table border=\"1\" width=\"100%\"><tbody><tr><td>Adults and children 12 years and over</td><td><list listType=\"unordered\"><item>Take 2 caplets at bedtime.</item><item>Do not take more than 2 caplets of this product in 24 hours.</item></list></td></tr><tr><td>Children under 12 years</td><td>Do not use</td></tr></tbody></table>"],"keep_out_of_reach_of_children":["Keep out of reach of children. Keep out of reach of children."],"openfda":{"application_number":["M013"],"brand_name":["Dr Simi Pain Reliever PM"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Farmacias De Similares TX LLC"],"package_ndc":["85786-101-90"],"product_ndc":["85786-101"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1092189"],"spl_id":["3c19ad99-6e10-3116-e063-6394a90a914c"],"spl_set_id":["3c19ad99-6e0f-3116-e063-6394a90a914c"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40"],"upc":["0850070048811"]},"other_safety_information":["Other information Store at 25 °C (77°F) excursions permitted between 15-30°C (59-86°F) Read all product information before using. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING"],"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":["DR SIMI NDC 85786-101-90 Extra Strength Pain Reliver PM Acetaminophen 500 mg Pain Reliever Diphenhydramine HCl 25 mg Nightime Sleep Aid 100 Caplets Aspirin Free Non-Habit Forming For Adults PDP1 TDF1"],"pregnancy":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Pupose Pain reliever Nighttime sleep aid"],"questions":["Questions or comments? (855)-280-1079"],"set_id":"3c19ad99-6e0f-3116-e063-6394a90a914c","spl_product_data_elements":["Dr Simi Pain Reliever PM Acetaminophen, Diphenhydramine Hydrochloride FD&C BLUE NO. 1 STARCH, CORN WATER ACETAMINOPHEN ACETAMINOPHEN FD&C BLUE NO. 2 STEARIC ACID HYPROMELLOSE, UNSPECIFIED DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED MAGNESIUM STEARATE POVIDONE K30 TITANIUM DIOXIDE APM"],"spl_unclassified_section":["Warnings Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take. More than 2 caplets in 24 hours, which is the maximum daily amount for this product. With other drugs containing acetaminophen. 3 or more alcoholicdrinks everyday 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 not prescription). 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 your doctor or pharmacist before use if you are Taking the blood thinning drug warfarin Taking sedative 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. 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.","Distributed by: FARMACIAS DE SIMILARES TX, LLC 800 Brazos St Ste 260, Austin, TX, 78701, USA. customerservice@drsimi.com www.drsimi.com LOT: EXP: PEEL BACK for more 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."],"version":"1","warnings":["Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take. More than 2 caplets in 24 hours, which is the maximum daily amount for this product. With other drugs containing acetaminophen. 3 or more alcoholicdrinks everyday 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."],"when_using":["When using this product Drowsiness will occur Avoid alcoholic drinks Do not drive a motor vehicle or operate machinery."]}