Naproxen Sodium Diphenhydramine HCL
Tablet · Oral
Active ingredient
Active ingredients (in each caplet) Diphenhydramine Hydrochloride 25 mg Naproxen Sodium 220 mg
Purpose
Purposes Nighttime sleep aid Pain reliever
Uses
Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
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 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 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 use more than directed or for longer than directed.
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
Ask a doctor before use
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 a 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 aspirin for heart attack or stroke, because naproxen may, decrease this benefit of aspirin
• taking any other antihistamines
• taking any other drug
When using this product
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
Stop use and ask a doctor
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 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 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
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.
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.
Directions
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 caplets at bedtime
• do not take more than 2 caplets in 24 hours
• if taken with food, this product may take longer to work
Other information
Other information
• each caplet contains: sodium 20 mg
• read all warnings and directions before use. Keep outer carton.
• store at 20 to 25°C (68 to 77°F).
• Avoid high humidity and excessive heat above 40°C (104°F).
Inactive ingredients
Inactive ingredients FD&C blue 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Questions?
Questions or comments? 1-888-287-1915
Label text from the FDA structured product label by Walmart (revised Dec 19, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Naproxen Sodium in 2 products
- Diphenhydramine Hydrochloride in 2 products
Naproxen Sodium Diphenhydramine HCL NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 69842-328 | Naproxen Sodium 220 mg/1; Diphenhydramine Hydrochloride 25 mg/1 Tablet, Film Coated | CVS PHARMACY, INC | ANDA |
| 79903-204 | Diphenhydramine Hydrochloride 25 mg/1; Naproxen Sodium 220 mg/1 Tablet | Walmart | ANDA |
Frequently asked questions
What is Naproxen Sodium Diphenhydramine HCL used for?
Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep
Who makes Naproxen Sodium Diphenhydramine HCL?
Naproxen Sodium Diphenhydramine HCL is listed by 2 labelers in the FDA NDC directory, including CVS PHARMACY, INC, Walmart.