{"active_ingredient":["Drug Facts Active ingredient (in each caplet) Acetaminophen 325 mg"],"ask_doctor":["Ask a doctor before use if the user has liver disease."],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin."],"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. if you are allergic to acetaminophen or any of the inactive ingredients in this product."],"dosage_and_administration":["Directions Adults and children 12 years and over Take 2 caplets every 4 to 6 hours while symptoms last. Do not take more than 10 caplets in 24 hours, unless directed by a doctor. Do not use for more than 10 days unless directed by a doctor. Children 6 years to under 12 years Take 1 caplet every 4 to 6 hours while symptoms last. Do not take more than 5 caplets in 24 hours. Do not use for more than 5 days unless directed by a doctor. Children under 6 years Ask a doctor"],"dosage_and_administration_table":["<table border=\"1\" width=\"100%\"><tbody><tr><td><paragraph>Adults and children 12 years and over</paragraph></td><td><list listType=\"unordered\"><item>Take 2 caplets every 4 to 6 hours while symptoms last.</item><item>Do not take more than 10 caplets in 24 hours, unless directed by a doctor.</item><item>Do not use for more than 10 days unless directed by a doctor.</item></list></td></tr><tr><td>Children 6 years to under 12 years</td><td><list listType=\"unordered\"><item>Take 1 caplet every 4 to 6 hours while symptoms last.</item><item>Do not take more than 5 caplets in 24 hours.</item><item>Do not use for more than 5 days unless directed by a doctor.</item></list></td></tr><tr><td>Children under 6 years</td><td>Ask a doctor</td></tr></tbody></table>"],"effective_time":"20250813","id":"3c477d33-a8c3-d39f-e063-6294a90ac5f0","inactive_ingredient":["Inactive ingredients Hypromellose, Magnesium stearate, Microcrystalline Cellulose , Polyethylene glycol 400, Povidone, Pregelatinized Starch, Purified water, Stearic acid , Talc, Titanium Dioxide."],"indications_and_usage":["Uses Temporarily relieves minor aches and pains due to: Headache. Muscular aches. Backache. Minor pain of arthritis. The common cold. Toothache. Premenstrual and menstrual cramps. Temporarily reduces fever.","Directions Do not take more than directed (see overdose warning). Directions Adults and children 12 years and over Take 2 caplets every 4 to 6 hours while symptoms last. Do not take more than 10 caplets in 24 hours, unless directed by a doctor. Do not use for more than 10 days unless directed by a doctor. Children 6 years to under 12 years Take 1 caplet every 4 to 6 hours while symptoms last. Do not take more than 5 caplets in 24 hours. Do not use for more than 5 days unless directed by a doctor. Children under 6 years Ask a doctor"],"indications_and_usage_table":["<table border=\"1\" width=\"100%\"><tbody><tr><td><paragraph>Adults and children 12 years and over</paragraph></td><td><list listType=\"unordered\"><item>Take 2 caplets every 4 to 6 hours while symptoms last.</item><item>Do not take more than 10 caplets in 24 hours, unless directed by a doctor.</item><item>Do not use for more than 10 days unless directed by a doctor.</item></list></td></tr><tr><td>Children 6 years to under 12 years</td><td><list listType=\"unordered\"><item>Take 1 caplet every 4 to 6 hours while symptoms last.</item><item>Do not take more than 5 caplets in 24 hours.</item><item>Do not use for more than 5 days unless directed by a doctor.</item></list></td></tr><tr><td>Children under 6 years</td><td>Ask a doctor</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 Relief"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["Farmacias De Similares TX LLC"],"package_ndc":["85786-103-90"],"product_ndc":["85786-103"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["313782"],"spl_id":["3c477d33-a8c3-d39f-e063-6294a90ac5f0"],"spl_set_id":["3c477d33-a8c2-d39f-e063-6294a90ac5f0"],"substance_name":["ACETAMINOPHEN"],"unii":["362O9ITL9D"],"upc":["0850070048552"]},"other_safety_information":["Other information Store between 20-25°C (68-77°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 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":["Principal display panel DR SIMI NDC 85786-103-90 Regular Strength Pain Reliever Acetaminophen 325 mg Pain Reliever/ Fever Reducer 100 Caplets Aspirin Free For Adults PDP1 DF1 Tabla Drug facts 2 Acetaminophen 325"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use."],"purpose":["Purpose Purpose Pain reliever / Fever reducer"],"questions":["Questions or comments? (855)-280-1079"],"set_id":"3c477d33-a8c2-d39f-e063-6294a90ac5f0","spl_product_data_elements":["Dr Simi Pain Relief Acetaminophen TITANIUM DIOXIDE WATER MAGNESIUM STEARATE ACETAMINOPHEN ACETAMINOPHEN HYPROMELLOSES POVIDONE K30 TALC POLYETHYLENE GLYCOL 400 STARCH, CORN MICROCRYSTALLINE CELLULOSE STEARIC ACID S325"],"spl_unclassified_section":["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 doctor if Pain gets worse or lasts more than 10 days in adults. Pain gets worse or lasts more than 5 days in children under 12 years. Fever gets worse or lasts more than 3 days. New symptoms occur. Redness or swelling is present. These could be signs of a serious condition."],"version":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. Severe liver damage may occur if: Adult takes more than 4,000 mg of acetaminophen in 24 hours. Child takes more than 5 doses in 24 hours, which is the maximum daily amount. Taken withother drugs containing acetaminophen. Adult has 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. if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if the user has liver disease. Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. Stop use and ask doctor if Pain gets worse or lasts more than 10 days in adults. Pain gets worse or lasts more than 5 days in children under 12 years. Fever gets worse or lasts more than 3 days. New symptoms occur. Redness or swelling is present. 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 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."]}