Ibuprofen Tablets, Usp 200 Mg

Ibuprofen Tablets, Usp 200 Mg
SPL v1
SPL
SPL Set ID 7ceacd63-d5fa-4cab-b8f3-a5131c97bb90
Route
ORAL
Published
Effective Date 2025-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Ferric Oxide Red Starch, Corn Polyethylene Glycol, Unspecified Povidone K30 Stearic Acid Sodium Starch Glycolate Type A Potato Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G2 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2011-01-01

Description

Drug Facts

Purpose

Pain reliever/ fever reducer


Medication Information

Purpose

Pain reliever/ fever reducer

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • toothache
    • muscular aches
    • backache
    • menstrual cramps
    • minor pain of arthritis
  • temporarily reduces fever
Section 42229-5

Drug Facts

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 any other pain reliever/fever reducer
  • right before or after heart surgery
Questions?

call toll free 1-844-912-4012

Inactive Ingredients

colloidal silicon dioxide, iron oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide.

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
  • 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
Keep Out of Reach of Children

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

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.

Active Ingredient (in Each Tablet)

Ibuprofen 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Package Label.principal Display Panel

IBUPROFEN TABLETS USP, 200 mg

Compare to the active ingredients in Advil ®Tablets*

*This product is not manufactured or distributed by the owner of the registered trademark Advil ®Tablets.







Ask A Doctor Or Pharmacist Before Use If You Are
  • 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

Structured Label Content

Uses (USES)
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • toothache
    • muscular aches
    • backache
    • menstrual cramps
    • minor pain of arthritis
  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Purpose (PURPOSE)

Pain reliever/ fever reducer

Warnings (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 (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 any other pain reliever/fever reducer
  • right before or after heart surgery
Questions? (QUESTIONS?)

call toll free 1-844-912-4012

Inactive Ingredients (INACTIVE INGREDIENTS)

colloidal silicon dioxide, iron oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide.

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
  • 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
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 (1-800-222-1222) right away.

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.

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (in each tablet))

Ibuprofen 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

IBUPROFEN TABLETS USP, 200 mg

Compare to the active ingredients in Advil ®Tablets*

*This product is not manufactured or distributed by the owner of the registered trademark Advil ®Tablets.







Ask A Doctor Or Pharmacist Before Use If You Are (ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE)
  • 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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)