Ibuprofen Tablets

Ibuprofen Tablets
SPL v3
SPL
SPL Set ID 113dd693-6abe-1a0f-e063-6394a90a167e
Route
ORAL
Published
Effective Date 2025-06-06
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Croscarmellose Sodium Hypromellose 2910 (6 Mpa.s) Microcrystalline Cellulose Polyethylene Glycol 400 Ferric Oxide Red Stearic Acid Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: N;II Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2024-05-15

Description

Active ingredient (in each tablet) Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Active ingredient (in each tablet) Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Uses
  • 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
Purposes

Pain reliever/Fever reducer

Warnings

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:
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

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

Directions
  • 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
Do Not Use
  • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery
Drug Facts

Active ingredient (in each tablet)



Ibuprofen USP 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing
  • see bottom panel for lot number and expiration date
Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, polyethylene glycol, red iron oxide, stearic acid, titanium dioxide and yellow iron oxide



Questions or comments?



Call 1-855-274-4122



DISTRIBUTED BY:

AMAZON.COM SERVICES LLC

410 TERRY AVENUE N., SEATTLE, WA 98109



Made in India

When Using This Product
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If
  • 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, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
Stop Use and Ask A Doctor If
  • 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
  • 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
  • any new symptoms appear
If Pregnant Or Breast Feeding,

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Ask A Doctor Or Pharmacist Before Use If You Are
  • 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
Package Label Principal Display Panel 200 Mg (100 Tablets Bottle)

amazon

basic+care

For Aches & Pains          

NDC 72288-513-10

Ibuprofen

Tablets USP 200 mg

Pain Reliever/

Fever Reducer

(NSAID)

100 COATED TABLETS

Package Label Principal Display Panel 200 Mg (100 Tablets Container Carton)

amazon

basic+care

For Aches & Pains  NDC 72288-513-10

Compare to the

active ingredinet

in Advil®**        

Ibuprofen

Tablets USP 200 mg

Pain Reliever/Fever Reducer (NSAID)

100 COATED TABLETS                           actual size




Structured Label Content

Uses
  • 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
Purposes

Pain reliever/Fever reducer

Warnings

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:
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

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

Directions
  • 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
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery
Drug Facts

Active ingredient (in each tablet)



Ibuprofen USP 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing
  • see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, polyethylene glycol, red iron oxide, stearic acid, titanium dioxide and yellow iron oxide



Questions or comments?



Call 1-855-274-4122



DISTRIBUTED BY:

AMAZON.COM SERVICES LLC

410 TERRY AVENUE N., SEATTLE, WA 98109



Made in India

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If (Ask a doctor before use if)
  • 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, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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
  • 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
  • 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 ibuprofen at 20 weeks or later in 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. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • 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
Package Label Principal Display Panel 200 Mg (100 Tablets Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Bottle))

amazon

basic+care

For Aches & Pains          

NDC 72288-513-10

Ibuprofen

Tablets USP 200 mg

Pain Reliever/

Fever Reducer

(NSAID)

100 COATED TABLETS

Package Label Principal Display Panel 200 Mg (100 Tablets Container Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (100 Tablets Container Carton))

amazon

basic+care

For Aches & Pains  NDC 72288-513-10

Compare to the

active ingredinet

in Advil®**        

Ibuprofen

Tablets USP 200 mg

Pain Reliever/Fever Reducer (NSAID)

100 COATED TABLETS                           actual size




Advanced Ingredient Data


Raw Label Data

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