equaline naproxen sodium pm DIPHENHYDRAMINE HYDROCHLORIDE NAPROXEN SODIUM UNITED NATURAL FOODS, INC. DBA UNFI FDA Approved Uses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep
FunFoxMeds box
Route
ORAL
Applications
ANDA208499

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Diphenhydramine hydrochloride 25 mg Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients croscarmellose sodium FD&C blue #1 aluminum lake FD&C blue #2 aluminum lake magnesium stearate microcrystalline cellulose polyethylene glycol polyvinyl alcohol povidone silicon dioxide 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 Helps You Fall Asleep And Stay Asleep
Pill Appearance
Shape: oval Color: blue Imprint: L264

Identifiers & Packaging

Container Type BOX
UNII
TC2D6JAD40 9TN87S3A3C
Packaging

Package/Label Principal Display Panel compare to Aleve ® pm active ingredients EQUALINE ® naproxen sodium PM naproxen sodium and diphenhydramine hydrochloride tablets, 220mg/25mg pain reliever (NSAID) / nighttime sleep-aid sleep aid plus 12 hour pain reliever actual size 50 caplets** **capsule-shaped tablets equaline-naproxen-sodium-pm-carton-image.jpg

Package Descriptions
  • Package/Label Principal Display Panel compare to Aleve ® pm active ingredients EQUALINE ® naproxen sodium PM naproxen sodium and diphenhydramine hydrochloride tablets, 220mg/25mg pain reliever (NSAID) / nighttime sleep-aid sleep aid plus 12 hour pain reliever actual size 50 caplets** **capsule-shaped tablets equaline-naproxen-sodium-pm-carton-image.jpg

Overview

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

Indications & Usage

Uses • for relief of occasional sleeplessness when associated 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
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 • 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. 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 • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • 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 problem 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 tranquilizers, or any other sleep-aid • under a doctor’s care for any serious condition • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin • 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 • 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 If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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 right away (1-800-222-1222).
Purpose

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

Storage & Handling

Other information • read all warnings and directions before use . Keep outer carton. • each caplet contains: sodium 21 mg • store at 20-25°C (68-77°F) • avoid high humidity and excessive heat above 40°C (104°F)

Questions

Questions or comments? 1-855-423-2630


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