Naproxen Sodium PM NAPROXEN SODIUM STRATEGIC SOURCING SERVICES LLC FDA Approved Uses for relief of occasional sleeplessness when associated with minor aches and pains help you fall asleep and stay asleep
FunFoxMeds box
Route
ORAL
Applications
ANDA209726
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Diphenhydramine hydrochloride 25 mg Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients carnauba wax FD&C blue #2 aluminum lake hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol povidone talc titanium dioxide
Strengths
25 mg 220 mg 200 mg
Treats Conditions
Uses For Relief Of Occasional Sleeplessness When Associated With Minor Aches And Pains Help You Fall Asleep And Stay Asleep
Pill Appearance
Shape: capsule Color: blue Imprint: AC37

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0010939921444
UNII
TC2D6JAD40 9TN87S3A3C
Packaging

Principal Display Panel COMPARE TO ALEVE® PM ACTIVE INGREDIENTS† Naproxen PM Naproxen Sodium 220 mg Pain reliever (NSAID) Diphenhydramine HCI 25 mg/ Nighttime sleep-aid COATED CAPLETS** (**CAPSULES-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. Another Quality Product Distributed by McKesson One Post Street, San Francisco, CA 94104 www.sunmarkbrand.com; Product Label SUNMARK Naproxen PM Diphenhydramine HCI 25 mg, Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Package Descriptions
  • Principal Display Panel COMPARE TO ALEVE® PM ACTIVE INGREDIENTS† Naproxen PM Naproxen Sodium 220 mg Pain reliever (NSAID) Diphenhydramine HCI 25 mg/ Nighttime sleep-aid COATED CAPLETS** (**CAPSULES-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. Another Quality Product Distributed by McKesson One Post Street, San Francisco, CA 94104 www.sunmarkbrand.com
  • Product Label SUNMARK Naproxen PM Diphenhydramine HCI 25 mg, Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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
Purpose

Purpose Nighttime sleep-aid Pain reliever

Do Not Use

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

When Using

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 & Ask a Doctor

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

Keep Out of Reach of Children

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.

Questions

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST


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