{"active_ingredient":["ACTIVE INGREDIENTS (in each tablet) Diphenhydramine hydrochloride, USP 25 mg Naproxen sodium, USP 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug"],"active_ingredient_table":["
Diphenhydramine hydrochloride, USP 25 mg
Naproxen sodium, USP 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
"],"ask_doctor":["ASK A DOCTOR BEFORE USE IF stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you have a breathing problem such as emphysema or chronic bronchitis you have glaucoma you have trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking sedatives or tranquilizers, or any other sleep-aid under a doctor’s care for any serious condition taking any other antihistamines 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 unless you have time for a full night’s sleep in children under 12 years of age right before or after heart surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain"],"dosage_and_administration":["DIRECTIONS do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 tablets at bedtime do not take more than 2 tablets in 24 hours if taken with food, this product may take longer to work Other information read all warnings and directions before use. Keep outer carton. each tablet contains: sodium 20 mg Tamper-evident : do not use if carton is opened or foil seal under cap, printed with \"SEALED for YOUR PROTECTION\" is missing, open or broken store at 20 to 25°C (68 to 77°F) avoid high humidity and excessive heat above 40°C (104°F)"],"effective_time":"20211021","id":"090ca040-1df1-412e-ae5a-8e2f7dbd9cf0","inactive_ingredient":["INACTIVE INGREDIENTS FD&C Blue # 2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, povidone titanium dioxide"],"indications_and_usage":["USES for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep"],"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 right away."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 20 Tablet Bottle Carton NDC 45963-220-20 Compare to the active ingredient in Aleve ® pm** Naproxen Sodium and Diphenhydramine Hydrochloride Tablets 220 mg/25 mg Pain Reliever (NSAID)/Nighttime Sleep-Aid SLEEP AID PLUS 12 Hour Pain Relief 20 Tablets carton_new"],"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":["PURPOSES Nighttime sleep-aid/Pain reliever"],"questions":["QUESTIONS? 1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday."],"set_id":"a7fa26f0-11df-4ddd-ae93-bf640372318b","spl_product_data_elements":["Naproxen Sodium and Diphenhydramine Hydrochloride Naproxen Sodium and Diphenhydramine Hydrochloride DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE NAPROXEN SODIUM NAPROXEN FD&C BLUE NO. 2 HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 3350 POVIDONE TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE ALUMINUM OXIDE NAP;PM;220;25 capsule shaped"],"spl_unclassified_section":["Drug Facts"],"stop_use":["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 you have symptoms of heart problems or stroke chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the pill is stuck in your throat"],"version":"13","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 direct Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed."],"when_using":["WHEN USING THIS PRODUCT drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs"]}