{"active_ingredient":["Drug Facts Active ingredient (in each caplet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *Nonsteroidal anti-inflammatory drug"],"ask_doctor":["Ask a doctor before use if The stomach bleeding warning applies to you. You have a history of stomach problems, such as heartburn You have high blood pressure, heart disease, liver cirrhosis, or kidney disease. You are taking a diuretic You have problems or serious side effects from taking pain relievers or fever reducers. You have asthma."],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are Under a doctor's care for any serious condition. Taking any other drug."],"do_not_use":["Do not use If you have ever had an allergic reaction to any other pain reliever/fever reducer. Right before or after heart surgery."],"dosage_and_administration":["Adults and children 12 years and over: Take 1 caplet every 8 to 12 hours while symptoms last. For the first dose you may take 2 caplets within the first hour. Do not exceed 2 caplets in any 8-12 hour period. Do not exceed 3 caplets in a 24-hour period. Children under 12 years: Ask a doctor."],"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 1 caplet every 8 to 12 hours while symptoms last.</item><item>For the first dose you may take 2 caplets within the first hour.</item><item>Do not exceed 2 caplets in any 8-12 hour period.</item><item>Do not exceed 3 caplets in a 24-hour period.</item></list></td></tr><tr><td>Children under 12 years:</td><td>Ask a doctor.</td></tr></tbody></table>"],"effective_time":"20250815","id":"3c6d4bb5-eb70-944b-e063-6294a90ae8de","inactive_ingredient":["Inactive ingredients Colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Lake, hypromellose, magnesium stearate, mirocrystalline cellulose, polyethylene glycol, povidone, titanium dioxide."],"indications_and_usage":["Directions Do not take more than directed. The smallest effective dose should be used Drink a full glass of water with each dose. Adults and children 12 years and over: Take 1 caplet every 8 to 12 hours while symptoms last. For the first dose you may take 2 caplets within the first hour. Do not exceed 2 caplets in any 8-12 hour period. Do not exceed 3 caplets in a 24-hour period. Children under 12 years: Ask a doctor."],"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 1 caplet every 8 to 12 hours while symptoms last.</item><item>For the first dose you may take 2 caplets within the first hour.</item><item>Do not exceed 2 caplets in any 8-12 hour period.</item><item>Do not exceed 3 caplets in a 24-hour period.</item></list></td></tr><tr><td>Children under 12 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":["ANDA091353"],"brand_name":["Dr Simi All Day Pain Relief"],"generic_name":["NAPROXEN SODIUM"],"is_original_packager":[true],"manufacturer_name":["Farmacias De Similares TX LLC"],"package_ndc":["85786-104-24"],"product_ndc":["85786-104"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["849574"],"spl_id":["3c6d4bb5-eb70-944b-e063-6294a90ae8de"],"spl_set_id":["3c6d4bb5-eb6f-944b-e063-6294a90ae8de"],"substance_name":["NAPROXEN SODIUM"],"unii":["9TN87S3A3C"],"upc":["0850072692876"]},"other_safety_information":["Other information Each tablet contains: sodium 20 mg. Store at room temperature 15-30°C (59-86°F). Read all product information before use."],"overdosage":["In case of overdose, get medical help or contact a Poison Control Center immediately."],"package_label_principal_display_panel":["DR SIMI NDC 85786-104-24 Strength to Last 12 hours Naproxen Sodium 220 mg Pain Reliever/Fever Reducer (NSAID) 24 Caplets PDP DF1 DF2"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health professional before use. It is especially important not to use Naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery."],"purpose":["Purpose Pain reliever/fever reducer"],"questions":["Questions or comments? (855)-280-1079"],"set_id":"3c6d4bb5-eb6f-944b-e063-6294a90ae8de","spl_product_data_elements":["Dr Simi All Day Pain Relief Naproxen sodium HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN SILICON DIOXIDE MAGNESIUM STEARATE POVIDONE K30 CROSCARMELLOSE SODIUM MICROCRYSTALLINE CELLULOSE FD&C BLUE NO. 2 ALUMINUM LAKE POLYETHYLENE GLYCOL, UNSPECIFIED 220 (Light Blue) (Capsule-Shaped)"],"spl_unclassified_section":["Uses Temporarily relieves minor aches and pains due to: Minor pain of arthritis. Backache. Headache. Muscular aches. Menstrual cramps. Toothache. The common cold. Temporarily reduces fever.","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 You experience any of the following signs of stomach bleeding: Feel faint. Have bloody or black stools. Vomit blood. Have stomach pain that does not get better. You have symptoms of heart problems or stroke: Chest Pain Trouble breathing Weakness in one side of the body Slurred speech Leg swelling Pain gets worse or lasts more than 10 days. Fever gets worse or lasts more than 3 days. You have difficulty swallowing. It feels like the pill is stuck in your throat. Redness or swelling is present in the painful area. Any new symptoms appear."],"version":"1","warnings":["Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: Hives Facial swelling Asthma (wheezing) Shock Skin reddening Rash Blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: Are age 60 or older. Have had stomach ulcers or bleeding problems. Take a blood thinning (anticoagulant) or steroid drug. Take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]. Have 3 or more alcoholic drinks every day while using this product. Take more or for a longer time than directed. Do not use If you have ever had an allergic reaction to any other pain reliever/fever reducer. Right before or after heart surgery. Ask a doctor before use if The stomach bleeding warning applies to you. You have a history of stomach problems, such as heartburn You have high blood pressure, heart disease, liver cirrhosis, or kidney disease. You are taking a diuretic You have problems or serious side effects from taking pain relievers or fever reducers. You have asthma. Ask a doctor or pharmacist before use if you are Under a doctor's care for any serious condition. Taking any other drug. When using this product Take with food or milk if stomach upset occurs. The risk of heart attack or stroke may increase if you use more than directed or for longer than directed. Stop use and ask doctor if You experience any of the following signs of stomach bleeding: Feel faint. Have bloody or black stools. Vomit blood. Have stomach pain that does not get better. You have symptoms of heart problems or stroke: Chest Pain Trouble breathing Weakness in one side of the body Slurred speech Leg swelling Pain gets worse or lasts more than 10 days. Fever gets worse or lasts more than 3 days. You have difficulty swallowing. It feels like the pill is stuck in your throat. Redness or swelling is present in the painful area. Any new symptoms appear. If pregnant or breast-feeding ask a health professional before use. It is especially important not to use Naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center immediately."],"when_using":["When using this product Take with food or milk if stomach upset occurs. The risk of heart attack or stroke may increase if you use more than directed or for longer than directed."]}