Naproxen Sodium PM: Package Insert and Label Information

NAPROXEN SODIUM PM- naproxen sodium and diphenhydramine hydrochloride tablet
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Active ingredient (in each caplet)

Diphenhydramine hydrochloride 25 mg

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

*nonsteroidal anti-inflammatory drug

Purpose

Nighttime sleep-aid

Pain reliever

Uses

  • for relief of occasional sleeplessness when associated with minor aches and pains
  • help 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

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

  • 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

  • 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

  • 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

  • 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

  • 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,

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.

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 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

  • 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

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

Questions or comments?

Call 1-888-309-9030

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

Diphenhydramine Hydrochloride 25 mg, Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
(click image for full-size original)

DOLLAR GENERAL Naproxen Sodium PM

NAPROXEN SODIUM PM
naproxen sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-854
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL, UNSPECIFIED
MAGNESIUM STEARATE
HYPROMELLOSES
POVIDONE
CELLULOSE, MICROCRYSTALLINE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code AC37
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55910-854-20 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 20 TABLET in 1 BOTTLE, PLASTIC This package is contained within the BOX (55910-854-20)
2 NDC:55910-854-40 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
2 40 TABLET in 1 BOTTLE, PLASTIC This package is contained within the BOX (55910-854-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209726 12/31/2018 09/30/2025
Labeler — Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Revised: 12/2022 Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.