Ibuprofen Tablets Usp 200 Mg

Ibuprofen Tablets Usp 200 Mg
SPL v6
SPL
SPL Set ID 119263b5-c3b7-46dc-a3bd-9893bfd24628
Route
ORAL
Published
Effective Date 2021-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Yellow No. 6 Starch, Corn Polyethylene Glycol, Unspecified Povidone K30 Polyvinyl Alcohol, Unspecified Sodium Starch Glycolate Type A Potato Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G2 Shape: capsule Color: orange Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2019-02-25

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

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

Drug Facts (continued)

Section 50565-1

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)

Section 50566-9

¬ chest pain ¬ trouble breathing

¬ leg swelling ¬ slurred speech

¬ weakness in one part or side of body

¬ 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

Section 53414-9

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.

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 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
Directions

¬ do not take more than directed

¬ the smallest effective dose should be used

¬ do not take longer than 10 days, unless directed by a

doctor (see Warnings)

¬ adults and children 12 years and over: take 1 caplet

every 4 to 6 hours while symptoms persist

¬ if pain or fever does not respond to 1 caplet, 2

caplets may be used

¬ do not exceed 6 caplets 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 to any other pain reliever/fever reducer
  • right before or after heart surgery
Drug Facts

Drug Facts

Active Ingredient

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information

¬ read all warnings and directions before use.

¬ store between 20°-25°C (68°-77°F)

¬ avoid excessive heat above 40°C (104°F)

Inactive Ingredients



colloidal silicon

dioxide, FD&C yellow no. 6, maize starch, polyethylene

glycol, polyvinyl alcohol, povidone k30,

pregelatinized starch, sodium starch glycolate, stearic

acid, talc, titanium dioxide.

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Ibuprofen

Ibuprofen Tablets 200 mg -

Pain reliever/fever reducer (NSAID)

When Using This Product

¬ 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

Ask A Doctor Before Use If

¬ the 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, 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:

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

Drug Facts (continued)

Section 50565-1 (50565-1)

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)

Section 50566-9 (50566-9)

¬ chest pain ¬ trouble breathing

¬ leg swelling ¬ slurred speech

¬ weakness in one part or side of body

¬ 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

Section 53414-9 (53414-9)

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.

Purpose

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 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
Directions

¬ do not take more than directed

¬ the smallest effective dose should be used

¬ do not take longer than 10 days, unless directed by a

doctor (see Warnings)

¬ adults and children 12 years and over: take 1 caplet

every 4 to 6 hours while symptoms persist

¬ if pain or fever does not respond to 1 caplet, 2

caplets may be used

¬ do not exceed 6 caplets 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 to any other pain reliever/fever reducer
  • right before or after heart surgery
Drug Facts

Drug Facts

Active Ingredient (Active ingredient)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information (Other information)

¬ read all warnings and directions before use.

¬ store between 20°-25°C (68°-77°F)

¬ avoid excessive heat above 40°C (104°F)

Inactive Ingredients (Inactive ingredients)



colloidal silicon

dioxide, FD&C yellow no. 6, maize starch, polyethylene

glycol, polyvinyl alcohol, povidone k30,

pregelatinized starch, sodium starch glycolate, stearic

acid, talc, titanium dioxide.

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Ibuprofen

Ibuprofen Tablets 200 mg -

Pain reliever/fever reducer (NSAID)

When Using This Product (When using this product)

¬ 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

Ask A Doctor Before Use If (Ask a doctor before use if)

¬ the 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, 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:

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

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