Naproxen Sodium Diphenhydramine Hydrochloride NAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDE SAFEWAY FDA Approved Uses ■ for relief of occasional sleeplessness when asscoiated with minor aches and pains ■ helps you fall asleep and stay asleep
FunFoxMeds box
Route
ORAL
Applications
ANDA213663
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients (in each caplet) Diphenhydramine Hydrochloride 25mg Naproxen Sodium 220mg
Inactive Ingredients
Inactive ingredients FD&C blue 2 aluminum lake hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol povidone talc titanium dioxide
Strengths
25 mg 220 mg
Treats Conditions
Uses For Relief Of Occasional Sleeplessness When Asscoiated With Minor Aches And Pains Helps You Fall Asleep And Stay Asleep
Pill Appearance
Shape: capsule Color: blue Imprint: G;17

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
TC2D6JAD40 9TN87S3A3C
Packaging

PDP Nap-Diphen 50ct

Package Descriptions
  • PDP Nap-Diphen 50ct

Overview

Uses ■ for relief of occasional sleeplessness when asscoiated with minor aches and pains ■ helps you fall asleep and stay asleep

Indications & Usage

Uses ■ for relief of occasional sleeplessness when asscoiated with minor aches and pains ■ helps 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 caplets at bedtime do not take more than 2 caplets in 24 hours if taken with food, this product may take longer to work

Warnings & Precautions
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 steriod 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.
Purpose

Purpose Pain Reliever/Nighttime sleep-aid Sleep Aid Plus

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 expereince 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

Keep Out of Reach of Children

Keep out of the reach of children In case of overdose, get medical help ot contact a Poison Control Center right away.

Storage & Handling

Other information ■ each caplet contains: sodium 20mg ■ read all warnings and directions before use. ​ Keep outer carton. ■ store at 20 to 25 °C (68 to 77 °F) ■ avoid high humidity and excessive heat above 40 °C (104 °F)

Questions

Questions or comments? call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST


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