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NDC 51824-0030-01 CAREALL Naproxen 220 mg/1 Details

CAREALL Naproxen 220 mg/1

CAREALL Naproxen is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by New World Imports, Inc.. The primary component is NAPROXEN SODIUM.

MedlinePlus Drug Summary

Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Related Packages: 51824-0030-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Naproxen

Product Information

NDC	51824-0030
Product ID	51824-030_014692c3-74d5-4811-a4fe-318b1fc4897a
Associated GPIs	66100060100303
GCN Sequence Number	021980
GCN Sequence Number Description	naproxen sodium TABLET 220 MG ORAL
HIC3	S2B
HIC3 Description	NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
GCN	47132
HICL Sequence Number	003726
HICL Sequence Number Description	NAPROXEN SODIUM
Brand/Generic	Generic
Proprietary Name	CAREALL Naproxen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Naproxen Sodium
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	220
Active Ingredient Units	mg/1
Substance Name	NAPROXEN SODIUM
Labeler Name	New World Imports, Inc.
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090545
Listing Certified Through	2022-12-31

Package

Package Images

NDC 51824-0030-01 (51824003001)

Pricing Information	N/A
NDC Package Code	51824-030-01
Billing NDC	51824003001
Package	100 CAPSULE in 1 BOTTLE, PLASTIC (51824-030-01)
Marketing Start Date	2013-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f3e21ed8-c9be-470e-a5d0-25b811b4933c Details

Active ingredients (in each tablet)

Naproxen 200mg

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 casue 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 mre 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

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.

The risk of heart attack or stroke may increase if you use more than directed of for longer than directed

Ask a Doctor

Ask a doctor before use if:

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 paiin relievers or fever reducers

You have asthma

Ask a doctor or pharmacist before use if you are:

under a doctors care for any serious condition

Taking any other drug

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, leg swelling, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, redness or swelling is present in the painful area, or 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.

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:

Take 1 caplet every 8 to 12 hours while symptoms last
For the first dose you may take 2 caplets within the first hour
Do not exceed 2 caplets in any 8 - 12 hour period
Do not exceed 3 caplets in a 24 hour period

Children under 12 years: ask a doctor

Inactive ingredients

FD and C blue number 2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide. May contain: corn starch, croscarmellose sodium, magnesium stearate, purified water, silicon dioxide, sodium starch glycolate, stearic acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL NAPROXEN

naproxen sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51824-030
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
water (UNII: 059QF0KO0R)
starch, corn (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	144
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51824-030-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090545	05/01/2013

Labeler - New World Imports, Inc. (075372276)

Revised: 10/2018

Document Id: 014692c3-74d5-4811-a4fe-318b1fc4897a

Set id: f3e21ed8-c9be-470e-a5d0-25b811b4933c

Version: 4

Effective Time: 20181022