NAPROXEN SODIUM PM- naproxen sodium tablet

Naproxen Sodium PM by

Drug Labeling and Warnings

Naproxen Sodium PM by is a Otc medication manufactured, distributed, or labeled by Freds Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

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 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

**Compare to the active ingredients in Aleve® PM

NAPROXEN pm

Naproxen Sodium 220 mg/Pain Reliever (NSAID)

Diphenhydramine HCI 25 mg/Nighttime sleep-aid

12 Hour Pain Relief Plus Sleep Aid

COATED CAPLETS†

(†CAPSULES-SHAPED TABLETS)

**This product is not manufactured or distributed by Bayer HealthCare, 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 INFORMATION.

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL ROAD,

MEMPHIS, TN 38118

www.fredsinc.com

Product Label

FRED'S PHARMACY Naproxen PM

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM PM 
naproxen sodium tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-844
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	AC37
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-844-20	1 in 1 BOX	02/28/2019
1		20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209726	02/28/2019

Labeler - Freds Inc (005866116)