CALMADOL PAIN RELIEVER NAPROXEN SODIUM GRANDALL DISTRIBUTING, LLC FDA Approved Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ common cold ■ muscular aches ■backache ■ toothache ■ menstrual cramps ■minor pain of arthritis ■temporarily reduces fever
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Substance Naproxen Sodium
Route
ORAL
Applications
ANDA090545
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg)(NSAID)*
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide croscarmellose sodium FD&C blue #2 lake hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol povidone titanium dioxide
Strengths
220 mg 200 mg
Quantities
24 tablets
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Common Cold Muscular Aches Backache Toothache Menstrual Cramps Minor Pain Of Arthritis Temporarily Reduces Fever
Pill Appearance
Shape: round Color: blue Imprint: 141

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
9TN87S3A3C
Packaging

Package Labeling CALMADOL PAIN RELIEVER FEVER REDUCER Naproxen Sodium Tablets 220 mg (NSAID) 24 TABLETS CalmadolTabLabel.jpg OuterCarton

Package Descriptions
  • Package Labeling CALMADOL PAIN RELIEVER FEVER REDUCER Naproxen Sodium Tablets 220 mg (NSAID) 24 TABLETS CalmadolTabLabel.jpg OuterCarton

Overview

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

Indications & Usage

Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ common cold ■ muscular aches ■backache ■ toothache ■ menstrual cramps ■minor pain of arthritis ■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 ■ blisters ■ rash 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 problems or serious side effects from taking pain relievers or fever reducers ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ 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
Purpose

Purpose Pain reliever/ fever reducer

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 If you have questions of a medical nature, please conact your pharmacist, doctor or health care professional.


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