First Aid Direct Naproxen Sodium Naproxen Sodium NAPROXEN SODIUM NAPROXEN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 POLYETHYLENE GLYCOL 1000 MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE STARCH, CORN TALC TITANIUM DIOXIDE Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever

First Aid Direct Naproxen Sodium Naproxen Sodium NAPROXEN SODIUM NAPROXEN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 POLYETHYLENE GLYCOL 1000 MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE STARCH, CORN TALC TITANIUM DIOXIDE

Mfr: OTC
FunFoxMeds box

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive Ingredients croscarmellose sodium FD&C Blue #2 macrogol magnesium stearate polyvinyl alcohol povidone pregelatinized starch talc and titanium dioxide
Strengths
220 mg 200 mg
Quantities
25 tablets 1 tablet
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Backache Muscular Aches Minor Pain Of Arthritis Menstrual Cramps Headache Toothache The Common Cold Temporarily Reduces Fever

Identifiers & Packaging

Container Type BOX
Packaging

Outer Package Label - NDC 42961-108-02 Naproxen Sodium 25 Tablets 1 Tablet per Packet Pain Reliever/Fever Reducer Compare active ingredients to Aleve®* Manufactured for: “fad first aid direct Mason, OH 45040 To dispense tablets: Open box top panel and remove this lower flap (and 2 other marked panels) along perforated edges. Then close box top panel (tab in slot) as it was before. Remove this flap along lower perforated edge. Active ingredients: Naproxen Sodium (NSAID) *This product is not manufactured or distributed by BAYER® owner of the registered trademark ALEVE®* Remove this lower flap along the two perforated edges. #121630 (1/21) 121630 outer-label-42961-108-02

Package Descriptions
  • Outer Package Label - NDC 42961-108-02 Naproxen Sodium 25 Tablets 1 Tablet per Packet Pain Reliever/Fever Reducer Compare active ingredients to Aleve®* Manufactured for: “fad first aid direct Mason, OH 45040 To dispense tablets: Open box top panel and remove this lower flap (and 2 other marked panels) along perforated edges. Then close box top panel (tab in slot) as it was before. Remove this flap along lower perforated edge. Active ingredients: Naproxen Sodium (NSAID) *This product is not manufactured or distributed by BAYER® owner of the registered trademark ALEVE®* Remove this lower flap along the two perforated edges. #121630 (1/21) 121630 outer-label-42961-108-02

Overview

Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever

Indications & Usage

Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever

Dosage & Administration

Directions do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose adults and children 12 years and older: take 1 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8 to 12-hour period do not exceed 3 tablets in a 24-hour period children under 12 years: ask a doctor

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 nonsprescription 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: NSAID, 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 right before or after heart surgery Ask a doctor before use if the stomach bleeding warning applies to you 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 problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask 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 fever gets worse or lasts more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear redness or swelling is present 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 right away.
Purpose

Purpose pain reliever/fever reducer

Do Not Use

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery

When Using

When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use & Ask a Doctor

Stop use and ask 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 fever gets worse or lasts more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear redness or swelling is present

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.

Questions

Questions? 1-800-327-2704 M-F 8a-4p


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