Fast Pain Relief

Manufacturer
We Care Distributor Inc. | Granules India Limited
Effective date
2015-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:26

Label at a glance#

ProductFast Pain Relief
Active ingredientIBUPROFEN
Label structure9 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active ingredient(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (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:
    • headache
    • toothache
    • backache
    • menstrual cramps
    • the common cold
    • muscular aches
    • minor pain of arthritis

  • 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
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

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


Stomach bleeding warning:

WARNINGS AND PRECAUTIONS SECTION

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

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

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • 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 a 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 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 right away.


DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and over: 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

SPL UNCLASSIFIED SECTION

  • each tablet contains: sodium 22 mg
  • read all warnings and directions before use
  • Keep carton or card
  • store at 20 - 25°C (68 - 77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, magnesium stearate,microcrystalline cellulose, talc, titanium dioxide


Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70005-009-25

SEE NEW WARNINGS AND DIRECTIONS

We Care

For Good Health

COMPARE TO ACTIVE INGREDIENT IN Advil®* CAPLETS

TO OPEN PUSH IN TAB AND PULL OUT

Ibuprofen 200 mg

Pain Reliever/Fever Reducer (NSAID)



  • Headache
  • Toothache
  • Minor Pain of Arthritis
  • Fever
  • Muscularache
  • Menstrual Cramps

Ibuprofen

*This product is not manufactured or distributed by Pfizer Healthcare, owner of the registered trademark of Advil®* tablets.

25 Pouches of 2 Coated Tablets



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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN1
310965ibuprofen 200 MG Oral TabletSCD1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70005-009-022020-01-31C16284748780-19d75b9d0-d6d8-f424-e053-dadaa90a57ceDrug Facts
70005-009-252020-01-31C16284748780-19d75b9d0-d6d8-f424-e053-dadaa90a57ceDrug Facts
70005-009-502020-01-31C16284748780-19d75b9d0-d6d8-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-009-02Fast Pain Relief4 in 1 POUCHTABLET, COATED41
70005-009-25Fast Pain Relief2 in 1 POUCHTABLET, COATED21
70005-009-25Fast Pain Relief25 in 1 CARTONTABLET, COATED251
70005-009-50Fast Pain Relief2 in 1 POUCHTABLET, COATED21
70005-009-50Fast Pain Relief50 in 1 CARTONTABLET, COATED501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-009FAST PAIN RELIEF (IBUPROFEN) TABLET, COATED [WE CARE DISTRIBUTOR INC.]1Legacy NDC, 5 package rows20151222_16b751a9-2f33-4303-b75f-ca0c012a212d.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70005-00970005-009-02, 70005-009-25, 70005-009-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

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
0a2f27ca-98e4-44f5-b812-b3803f61f76216b751a9-2f33-4303-b75f-ca0c012a212d2015-12-02WarningsExact identifier
spl id: 0a2f27ca-98e4-44f5-b812-b3803f61f762
spl set id: 16b751a9-2f33-4303-b75f-ca0c012a212d

Reported adverse events (FAERS/openFDA)#

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