Medicine guide

Naproxen Sodium Pm

25 mg + 220 mg · Tablet, Film Coated

  • Available without prescription
  • Histamine-1 Receptor Antagonist
Made by
Meijer Distribution 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 · 2026-07-07

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
11other products contain Diphenhydramine Hydrochloride, Naproxen Sodium — 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 · 2026-07-07 · DailyMed

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 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

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 you use more than directed or for longer than directed.
  • Do not use
  • if you have sleeplessness without pain Ask a doctor before use if
  • Ask a doctor or pharmacist before use
  • if you are
  • taking any other drug 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 if
  • feel faint
  • vomit blood
  • chest pain
  • leg swelling
  • it 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 at 20 weeks or later in 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 right away (1-800-222-1222).
  • 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 at 20 weeks or later in 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 (1-800-222-1222).

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

Other information

  • read all warnings and directions before use. Keep outer carton.
  • each caplet contains: sodium 21 mg
  • store at 20-25°C (68-77°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.

croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

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

Questions about this product

1-800-719-9260

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 #1 aluminum lake; FD&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.

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

Details

Made byMeijer Distribution Inc
Active substanceDiphenhydramine Hydrochloride, Naproxen Sodium
Used inMuscles, joints and bones
Strength25 mg + 220 mg
FormTablet, Film Coated
RouteOral
Packs1 BOTTLE in 1 CARTON / 80 TABLET, FILM COATED in 1 BOTTLE
NDC41250-526

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).

Other strengths and forms

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

Same active substance

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