CAREALL Naproxen

Manufacturer
New World Imports, Inc.
Effective date
2019-01-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:15

Label at a glance#

ProductCAREALL Naproxen
Active ingredientNAPROXEN SODIUM
Label structure10 sections

Indications and 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

Dosage and 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 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 d...

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Naproxen sodium 220mg

(Naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever / fever reducer

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product:

Take with food or milk if stomach upset occurs. 

Ask a Doctor

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NAPC220100 Label.jpgNAPC220100 Label.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849574naproxen sodium 220 MG Oral TabletPSN1
849574naproxen sodium 220 MG Oral TabletSCD1
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51824-071-012021-01-29C16284748780-1ba0f9c33-38bb-a910-e053-dadaa90a0b8584475072-7696-4273-822f-2b3b3244eb70

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-071-01CAREALL Naproxen100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-071CAREALL NAPROXEN (NAPROXEN SODIUM) TABLET [NEW WORLD IMPORTS, INC.]1Legacy NDC, 1 package rows20190118_84475072-7696-4273-822f-2b3b3244eb70.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51824-07151824-071-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079096-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2008-12-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1684e616aacf4f…
2026-08-18 06:07:402026-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09A079096-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2008-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A079096-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2008-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079096-001NAPROXEN SODIUM220MGTABLET / ORAL2008-12-16f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3704f1e5-7e60-444f-a651-fce02c134b1484475072-7696-4273-822f-2b3b3244eb702019-01-14WarningsExact identifier
spl id: 3704f1e5-7e60-444f-a651-fce02c134b14
spl set id: 84475072-7696-4273-822f-2b3b3244eb70

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.