Naproxen Sodium PM

Manufacturer
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Effective date
2022-12-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:45:39

Label at a glance#

ProductNaproxen Sodium PM
Active ingredientNAPROXEN SODIUM, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure17 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 25 mg

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Pain reliever

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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
  • 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 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

OTC - DO NOT USE SECTION

  • 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 if

OTC - ASK DOCTOR SECTION

  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducer
  • 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 such as emphysema or chronic bronchitis
  • you have glaucoma
  • you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizer, or any other sleep-aid
  • under a doctor’s care for any serious condition
  • taking any other antihistamines
  • taking any other drug

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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 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 last 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

  • each tablet contains: sodium 20 mg
  • read all warnings and directions before use. Keep carton.
  • store between 20º 25ºC (68º-77ºF)
  • avoid high humidity and excessive heat above 40ºC (104ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-309-9030

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients of Aleve® PM**

Naproxen Sodium PM

Naproxen Sodium 220 mg/

Pain reliever (NSAID)

Diphenhydramine HCI 25 mg/

Nighttime sleep-aid

Caplets

(†Capsule-Shaped Tablets)

**This product is not manufactured or distributed by Bayer Health Care, LLC, distributor of Aleve® PM

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INGORMATION.

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOLLAR GENERAL Naproxen Sodium PM
DOLLAR GENERAL Naproxen Sodium PM

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-854NAPROXEN SODIUM PM (NAPROXEN SODIUM) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]3Legacy NDC20221203_a16d1925-c01e-4a00-ba01-e9d699b65e7d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-85455910-854-20, 55910-854-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM25MG;220MGTABLET / ORAL2018-10-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-2384e616aacf4f…
2026-08-18 06:07:402026-07A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-233f01610625f2…
2019-09-15 20:21 UTC2019-09A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209726-001NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;220MGTABLET / ORAL2018-10-23f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a662cc95-9cef-4ee0-a4bd-c75b20392d78a16d1925-c01e-4a00-ba01-e9d699b65e7d2022-12-02WarningsExact identifier
spl id: a662cc95-9cef-4ee0-a4bd-c75b20392d78
spl set id: a16d1925-c01e-4a00-ba01-e9d699b65e7d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.