{"active_ingredient":["Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug"],"dosage_and_administration":["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 older ■ take 1 tablet every 8 to12 hours while symptoms last ■ for the first dose, you may take 2 tablets within the first hour ■ do not exceed 2 tablets in any 8-to 12-hour period ■ do not exceed 3 tablets in a 24-hour period ■ children under 12 years: ask a doctor"],"effective_time":"20200518","id":"5ac02446-13da-43d5-9647-fe469294acec","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, FD & C Blue#2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide, talc"],"indications_and_usage":["Uses ■ temporarily relieves minor aches and pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ menstrual cramps ■ minor pain of arthritis ■ temporarily reduces fever"],"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 (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA205497"],"brand_name":["Ana-Dent PAIN RELIEF"],"generic_name":["NAPROXEN SODIUM"],"is_original_packager":[true],"manufacturer_name":["Belmora LLC"],"package_ndc":["27854-701-01"],"product_ndc":["27854-701"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["849574"],"spl_id":["5ac02446-13da-43d5-9647-fe469294acec"],"spl_set_id":["04721306-2850-4e0a-9dd9-7cabb575f3c7"],"substance_name":["NAPROXEN SODIUM"],"unii":["9TN87S3A3C"]},"package_label_principal_display_panel":["Packaging Flx701"],"purpose":["Purpose Pain reliever/ fever reducer"],"questions":["Questions or comments? Call 1-888-779-2877 M-F 9AM-5PM EST"],"set_id":"04721306-2850-4e0a-9dd9-7cabb575f3c7","spl_product_data_elements":["Ana-Dent PAIN RELIEF Naproxen Sodium NAPROXEN SODIUM NAPROXEN SILICON DIOXIDE FD&C BLUE NO. 2 HYPROMELLOSE 2910 (5 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 8000 POVIDONE K30 TITANIUM DIOXIDE TALC light blue Circular J;67"],"spl_unclassified_section":["Drug Facts","For toothaches KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION Distributed by Belmora LLC, 2011 Crystal Dr. Suite 400 Arlington, VA 22202 www.anadentusa.com Made in India TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING"],"storage_and_handling":["Other information ■ each tablet contains: sodium 20 mg ■ store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) ■ see end flap for expiration date and lot number"],"version":"1","warnings":["Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ shock ■ facial swelling ■ asthma (wheezing) ■ hives ■ skin reddening ■ blisters ■ rash 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 ■ have had stomach ulcers or bleeding problems ■ take blood thinning (anticoagulant) or steroid drug ■ are age 60 or older ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ take more or for a longer time than directed ■ have 3 or more alcoholic drinks every day while using this product. Do not use ■ right before or after heart surgery ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer 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 asthma ■ you have high blood pressure, heart disease, liver cirrhosis or kidney disease ■ you have a problems or serious side effects from taking pain relievers or fever reducers ■ you are taking a diuretic 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 a doctor if ■ you experience any of the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better ■ 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."]}