CAREALL NAPROXEN- naproxen sodium tablet 
New World Imports, Inc.

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Active ingredients (in each caplet)

Active ingredient (in each caplet)

Naproxen sodium 220mg

(Naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever / fever reducer

Uses

Temporarily relieves minor aches and pains due to: minor pain of arthritis, backache, headache, muscular aches, menstrual cramps, toothache, 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 NSAID, which may casue 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 everyday while using this product, take more or for a longer time than directed.

Heart attack and stroke warning: NSAIDs, except aspirin, increase the rist 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 

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 this product

When using this product:

Take with food or milk if stomach upset occurs. 

Ask a Doctor

Ask a doctor before use if:

The stomach bleeding warning applies to you

You ahve 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 drugs

Stop use and ask a doctor

Stop use and ask a doctor if:

You experience any of the following signs of stomach bleeding: you feel faint, vomit blood, have bloddy 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, or 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

If pregnant or breast-feeding

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 definately 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


Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Directions

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:

Children under 12 years: ask a doctor

Inactive ingredients

croscarmellose sodium, FD&C blue number 2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

NAPC220100
CAREALL NAPROXEN 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-072
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize12mm
FlavorImprint Code 17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-072-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07909601/16/2019
Labeler - New World Imports, Inc. (075372276)

Revised: 11/2023
Document Id: 5eeae4dc-b15f-4f3b-b88e-c4c2371179ab
Set id: d9a0c6e7-a70e-479a-9737-e81a2887c778
Version: 2
Effective Time: 20231130
 
New World Imports, Inc.