Nuprin ® IBUPROFEN TABLETS, USP 200mg Drug Facts

Manufacturer
Strides Arcolab Limited | Shasun Pharmaceuticals Limited
Effective date
2016-02-04
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:29:14

Label at a glance#

ProductNUPRIN IMMEDIATE RELEASE
Active ingredientIBUPROFEN
Label structure13 sections

Dosage and administration

• do not take more than directed • the smallest effective dose should be used adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor OTHER INFORMATION store between 20 – 25°C (68-77°F) tamper evident: do no...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Ibuprofen USP 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USE(S)

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:

  • hives
  • facial swelling
  • rash
  • blisters
  • shock
  • skin reddening
  • asthma (wheezing)

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains a nonsteroidal anti-inflammatory drug (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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

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

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • 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 DOCTOR IF

OTC - STOP USE SECTION

  • 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 3days
  • 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 ibuprofen 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• do not take more than directed
• the smallest effective dose should be used



adults and children 12 years and older
  • take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor

children under 12 years


  • ask a doctor


OTHER INFORMATION

  • store between 20 – 25°C (68-77°F)
  • tamper evident: do not use if imprinted safety seal under cap is broken or missing
  • see end panel for lot number and expiration date

INACTIVE INGREDIENT (S)

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin

QUESTIONS OR COMMENTS?
Adverse drug event Call (877)-244-9825


MADE IN INDIA

Mfg.Lic.No. DRUGS/PY/05 13 1523

NUPRIN® is a registered trademark of SVADS Holdings SA


Manufactured for:

Strides Pharma Inc,


East Brunswick, NJ 08816
www.nuprin.com
December 2015

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label (Round Shaped Tablets) - Principal Display Panel, 200 mg Tablets
NDC 64380-788-31
400 Coated Tablets
N TM Nuprin®
IBUPROFEN TABLETS,USP
200 mg
Pain Reliever/Fever Reducer (NSAID)*
*nonsteroidal anti-inflammatory drug.
400s-label400s-label
400s-carton400s-carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130364380788317GTIN-13: 0364380788317
EAN-13: 0364380788317
GTIN-12: 364380788317
UPC-A: 364380788317
GTIN storage (14 digits): 00364380788317
Nuprin-200mg-400s-carton.jpg, Nuprin-200mg-400s-label.jpg

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64380-78864380-788-31

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
A079129-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-03-28

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 22:38:342026-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28f41ea6bd6efb…

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
41e63bd3-e4ec-4785-b2a4-95545ae2b42378de585a-6b73-4151-93bd-d73fa74a96142023-05-31WarningsExact identifier
spl set id: 78de585a-6b73-4151-93bd-d73fa74a9614

Reported adverse events (FAERS/openFDA)#

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