all day relief description, usages, side effects, indications, overdosage, supplying and lots more!

all day relief

Meijer Distribution Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Meijer Distribution, Inc. All Day Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

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

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

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, or kidney disease
  • •you are taking a diuretic
  • •you have problems or serious side effects from taking pain relievers or fever reducers
  • •you have asthma

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 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
  • •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

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. (1-800-222-1222)

Directions

  • •do not take more than directed
  • •the smallest effective dose should be used
  • •drink a full glass of water with each dose

Other information

  • •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).

Inactive ingredients

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions?

1-800-719-9260

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Compare to Aleve® active ingredient

Easy Open Cap

SEE NEW WARNINGS INFORMATION

Strength to Last 12 Hours

All Day Relief

Naproxen Sodium Tablets, 220 mg

Pain Reliever/Fever Reducer (NSAID)

Actual Size

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

220 mg Each

(**capsule shaped tablets)

all day relief

Naproxen sodium TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41250-140
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naproxen sodium NAPROXEN 220 mg

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
talc
titanium dioxide
POVIDONES

Product Characteristics

Color Size Imprint Code Shape
BLUE (light blue) 12 mm L368 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41250-140-82 200 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074661 2004-05-28


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