Mediclarum
Medicine guide

Naproxen Sodium Diphenhydramine Hcl

220 mg + 25 mg · Tablet, Film Coated

  • Available without prescription
  • Histamine-1 Receptor Antagonist
Made by
CVS PHARMACY, INC

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-12-19

What it is

Nighttime sleep aid Pain reliever

Used for
  • For relief of occasional sleeplessness when associated with minor aches and pains
  • Helps you fall asleep and stay asleep
How to take it

Adults and children 12 years and over: take 2 caplets at bedtime

do not take more than 2 caplets in 24 hours

Full directions ↓
Do not take it if

If you have ever had an allergic reaction to any other pain reliever/fever reducer

All warnings ↓
Good to know
  • Sold without a prescription
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
1other products contain Naproxen Sodium Diphenhydramine Hcl — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep

From the official label · 2025-12-19 · DailyMed

How it works

From the US prescribing label for the same active substance (Naproxen). It describes the substance, not this exact product.

Naproxen has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of naproxen, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Peak level after2–4 h
Half-life12–17 h
Mostly cleared after≈ 3 daysfive half-lives — our arithmetic
PeakHalf gone3 days0
The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.
How the body breaks it down

Naproxen is extensively metabolized in the liver to 6-0-desmethyl naproxen, and both parent and metabolites do not induce metabolizing enzymes.

How it leaves the body

Approximately 95% of the naproxen from any dose is excreted in the urine, primarily as naproxen (<1%), 6-0-desmethyl naproxen (<1%) or their conjugates (66% to 92%).

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-18

Do not take it if

  • 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

Quoted from the official label, section “OTC — Do Not Use”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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

Quoted from the official label, section “Dosage & Administration”.

Ask a doctor first 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

Quoted from the official label, section “OTC — Ask Doctor”.

Ask a pharmacist first 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

Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.

Stop and get help 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 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

Quoted from the official label, section “OTC — Stop Use”.

Other 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
  • 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.
  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
  • take with food or milk if stomach upset occurs

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • 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

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Keep away from children

In case of overdose, get medical help or contact a Poison Control Center right away.

Quoted from the official label, section “OTC — Keep Out of Reach of Children”.

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)

Quoted from the official label, section “OTC — Other Information”.

What kind of medicine it is

Nighttime sleep aid Pain reliever

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

FD&C blue 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide.

Quoted from the official label, section “Inactive Ingredients”.

Questions about this product

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Quoted from the official label, section “OTC — Questions”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Colour dyesFD&C blue 2 aluminum lakeSome people react to dyes such as tartrazine (Yellow 5) or carmine.
  • Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (3)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Hide versions whose label lists:

Showing 3 of 3

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (45)

NetherlandsNo exact match for this strength and form

Every strength and form (24)

Details

Made byCVS PHARMACY, INC
Active substanceNaproxen Sodium Diphenhydramine Hcl
Used inMuscles, joints and bones
Strength220 mg + 25 mg
FormTablet, Film Coated
RouteOral
Packs20 TABLET, FILM COATED in 1 BOTTLE
NDC69842-328

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

  • Tablet, Film Coated1 products
    • 220 mg + 25 mg
  • Tablet1 products

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Naproxen Sodium Diphenhydramine Hcl25 mg + 220 mgWithout prescriptionTablet Walmart · Naproxen Sodium Diphenhydramine Hcl

See every product with Naproxen Sodium Diphenhydramine Hcl