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

Purpose

Pain reliever/fever reducer

Description

Drug Facts


Medication Information

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
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
Purpose

Pain reliever/fever reducer

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

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.

Description

Drug Facts

Principal Display Panel

Ibuprofen

Ibuprofen Tablets 200 mg -

Pain reliever/fever reducer (NSAID)

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.

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

Questions Or Comments?

1-888-333-9792

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

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
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
Purpose

Pain reliever/fever reducer

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

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Ibuprofen

Ibuprofen Tablets 200 mg -

Pain reliever/fever reducer (NSAID)

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.

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

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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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