SPL v3
SPL
SPL Set ID c01538b0-ca4c-434a-be8f-fe023deb84e1
Route
ORAL
Published
Effective Date 2015-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Croscarmellose Sodium Carnauba Wax Hypromelloses Polyethylene Glycol 400 Stearic Acid Cellulose, Microcrystalline Povidone K30 Starch, Pregelatinized Corn Polysorbate 80 Silicon Dioxide Titanium Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: IBU200 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2015-03-31

Description

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


Medication Information

Warnings and Precautions

Warnings:

Allergy Alert: Ibuprofen may cause a severe allergic

reaction which may include:

• hives • shock • facial swelling • asthma (wheezing)

Alcohol Warning: If you consume 3 or more alcoholic

drinks every day, ask your doctor whether you should

take Ibuprofen or other pain relievers/ fever reducers.

Ibuprofen may cause stomach bleeding.

Do not use:

• if you have ever had an allergic reaction to any

other pain reliever/fever reducer

Ask a doctor before use if you have:

• stomach pain

• problems or serious side eects from taking

pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are:

• under a doctor's care for any serious condition

• taking any other drug

• taking any other product that contains Ibuprofen,

or any other pain reliever/fever reducer

When using this product give with food or milk if

stomach upset occurs.

Stop use and ask a doctor if:

• an allergic reaction occurs. Seek medical help right

away • pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

• stomach pain or upset gets worse or lasts

• any new symptoms appear • redness or swelling is

present in the painful area

Indications and Usage

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

Dosage and Administration

Directions:

• Do not take more than directed.

Adults and children 12 years and older

• Take 1  tablet every 4 to 6  hours while symptoms

• If pain or fever does not respond to 1 tablet, 2 tablets may be used.

Do not exceed 6 tablets in 24 hours, unless as directed by a doctor.

• The smallest effective dose should be used.

Children under 12 year

• Ask a doctor.

Description

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

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. In

case of overdose, get medical help or

contact a Poison Control Center right

away.

Section 51727-6

Inactive Ingredients:

carnauba wax, croscarmellose sodium,

hydroxypropyl methylcellulose,

microcrystalline cellulose,

polyethylene glycol, polysorbate 80,

povidone, pregelatinized starch, silicon

dioxide, sodium starch glycolate,

stearic acid and titanium dioxide.

Section 51945-4

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 directed to do so by a doctor because it may

cause problems in the unborn

child or complications during delivery.

Section 55105-1

PAIN RELIEVER/FEVER REDUCER

Section 55106-9

ACTIVE INGREDIENT-IBUPROFEN 200 MG


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions:

• Do not take more than directed.

Adults and children 12 years and older

• Take 1  tablet every 4 to 6  hours while symptoms

• If pain or fever does not respond to 1 tablet, 2 tablets may be used.

Do not exceed 6 tablets in 24 hours, unless as directed by a doctor.

• The smallest effective dose should be used.

Children under 12 year

• Ask a doctor.

Warnings and Precautions (34071-1)

Warnings:

Allergy Alert: Ibuprofen may cause a severe allergic

reaction which may include:

• hives • shock • facial swelling • asthma (wheezing)

Alcohol Warning: If you consume 3 or more alcoholic

drinks every day, ask your doctor whether you should

take Ibuprofen or other pain relievers/ fever reducers.

Ibuprofen may cause stomach bleeding.

Do not use:

• if you have ever had an allergic reaction to any

other pain reliever/fever reducer

Ask a doctor before use if you have:

• stomach pain

• problems or serious side eects from taking

pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are:

• under a doctor's care for any serious condition

• taking any other drug

• taking any other product that contains Ibuprofen,

or any other pain reliever/fever reducer

When using this product give with food or milk if

stomach upset occurs.

Stop use and ask a doctor if:

• an allergic reaction occurs. Seek medical help right

away • pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

• stomach pain or upset gets worse or lasts

• any new symptoms appear • redness or swelling is

present in the painful area

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.

Section 51727-6 (51727-6)

Inactive Ingredients:

carnauba wax, croscarmellose sodium,

hydroxypropyl methylcellulose,

microcrystalline cellulose,

polyethylene glycol, polysorbate 80,

povidone, pregelatinized starch, silicon

dioxide, sodium starch glycolate,

stearic acid and titanium dioxide.

Section 51945-4 (51945-4)

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 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)

PAIN RELIEVER/FEVER REDUCER

Section 55106-9 (55106-9)

ACTIVE INGREDIENT-IBUPROFEN 200 MG


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)