The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Diphenhydramine hydrochloride 25 mgNaproxen sodium 220 mg (naproxen 200 mg) (NSAID)**nonsteroidal anti-inflammatory drug
Nighttime sleep-aidPain reliever
- For relief of occasional sleeplessness when associated with minor aches and painshelp you fall asleep and stay asleep
- Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hives
- Facial swelling
- Asthma (wheezing)
- Skin reddening
- BlistersIf 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
- Have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- Take more or for a longer time than directedHeart 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
Do Not Use
- If you have ever had an allergic reaction to any other pain reliever/fever reducerunless you have time for a full night's sleepin children under 12 years of ageright before or after heart surgery with any other product containing diphenhydramine, even one used on skinif you have sleeplessness without pain
Ask A Doctor Before Use If
- The stomach bleeding warning applies to youyou have problems or serious side effects from taking pain relievers or fever reduceryou 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 such as emphysema or chronic bronchitisyou have glaucomayou have trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
- Taking sedatives or tranquilizer, or any other sleep-aidunder a doctor’s care for any serious condition taking any other antihistaminestaking any other drug
When Using This Product
- Drowsiness will occuravoid alcoholic drinksdo not drive a motor vehicle or operate machinerytake with food or milk if stomach upset occurs
Stop Use And Ask A 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 betteryou have symptoms of heart problems or strokechest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain gets worse or last more than 10 dayssleeplessness 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 areaany new symptoms appear you have difficulty swallowingit feels like the pill is stuck in your throat
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.
- Do not take more than directeddrink a full glass of water with each dose
- Adults and children 12 years and over:take 2 tablets at bedtimedo not take more than 2 tablets in 24 hours if taken with food, this product may take longer to work
- Each tablet contains: sodium 20 mgread all warnings and directions before use. Keep carton.store between 20º- 25ºC (68º-77ºF)avoid high humidity and excessive heat above 40ºC (104ºF)
Carnauba wax, FD&C blue #2, aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
FRED'S PHARMACY Naproxen PM
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