{"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 ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland"],"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 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 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":["
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":"20260410","id":"4f1e1f1a-44f5-2356-e063-6294a90a8cdd","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, 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. 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."],"openfda":{"application_number":["M013"],"brand_name":["Dr. Simi Pain Reliever PM"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE HCL"],"is_original_packager":[true],"manufacturer_name":["Farmacias De Similares TX LLC"],"package_ndc":["85786-108-24"],"product_ndc":["85786-108"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1092189"],"spl_id":["4f1e1f1a-44f5-2356-e063-6294a90a8cdd"],"spl_set_id":["4f1e1f1a-44f4-2356-e063-6294a90a8cdd"],"substance_name":["DIPHENHYDRAMINE HCL","ACETAMINOPHEN"],"unii":["TC2D6JAD40","362O9ITL9D"]},"other_safety_information":["Other information ■ store between 20-25°C (68-77°F) in a dry place ■ retain carton for complete product information"],"package_label_principal_display_panel":["Carton labeling Carton labeling"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep aid"],"purpose_table":["
Acetaminophen 500 mg
Pain reliever
Diphenhydramine HCl 25 mg
Nighttime sleep aid
"],"questions":["Questions or comments? 855-280-1079"],"set_id":"4f1e1f1a-44f4-2356-e063-6294a90a8cdd","spl_product_data_elements":["Dr. Simi Pain Reliever PM Acetaminophen, Diphenhydramine HCl STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A CORN MICROCRYSTALLINE CELLULOSE TITANIUM DIOXIDE STEARIC ACID DIPHENHYDRAMINE HCL DIPHENHYDRAMINE SILICON DIOXIDE LACTOSE, UNSPECIFIED FORM POLYETHYLENE GLYCOL, UNSPECIFIED CROSCARMELLOSE SODIUM MAGNESIUM STEARATE ACETAMINOPHEN ACETAMINOPHEN FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED COPOVIDONE K25-31 POVIDONE AAA;1031"],"spl_unclassified_section":["Principal Display Panel NDC: 85786-108-24 DR. SIMI Extra strength Pain Reliever PM Acetaminophen 500 mg Diphenhydramine HCl 25 mg Pain Reliever / Nighttime Sleep Aid For Adults 24 Caplets †Compare to the active ingredients in Tylenol® PM Extra Strength Caplets †This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® PM Extra Strength Caplets. DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROJEN OR MISSING Distributed by: FARMACIAS DE SIMILARES TX LLC 800 Brazos St Ste 260, Austin, TX, 78701, USA customerservice@drsimi.com www.drsimi.com"],"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":["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 ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland 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 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"]}