611r Leader Cardinal 70000-0597 Ibuprofen Tablets Usp 200 Mg

611r Leader Cardinal 70000-0597 Ibuprofen Tablets Usp 200 Mg
SPL v1
SPL
SPL Set ID dfbbde4f-633d-6d57-e053-2a95a90ad82f
Route
ORAL
Published
Effective Date 2022-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Titanium Dioxide Silicon Dioxide Croscarmellose Sodium Starch, Corn Talc Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: 115 Shape: round Color: orange Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2022-05-25

Description

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


Medication Information

Warnings and Precautions

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.



Indications and Usage

Uses

• temporarily relieves minor aches and pains due to:

o headache

o muscular aches

o minor pain of arthritis

o toothache

o backache

o the common cold

o menstrual cramps

• temporarily reduces fever



Dosage and Administration

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

Description

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

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

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



Section 50567-7

When using this product

• take with food or milk if stomach upset occurs

Section 50568-5

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

Section 50569-3

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

Section 50570-1

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



Section 51727-6

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments? Call 1-877-290-4008

Section 53414-9

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.

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8

Other information

• store at 20-25ºC (68-77ºF)


Structured Label Content

Indications and Usage (34067-9)

Uses

• temporarily relieves minor aches and pains due to:

o headache

o muscular aches

o minor pain of arthritis

o toothache

o backache

o the common cold

o menstrual cramps

• temporarily reduces fever



Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.



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)

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



Section 50567-7 (50567-7)

When using this product

• take with food or milk if stomach upset occurs

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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



Section 51727-6 (51727-6)

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-877-290-4008

Section 53414-9 (53414-9)

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.

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

Other information

• store at 20-25ºC (68-77ºF)


Advanced Ingredient Data


Raw Label Data

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