motrin ib

motrin ib
SPL v1
SPL
SPL Set ID 8d6fe91b-49d1-1af2-e053-2995a90a1777
Route
oral
Published
Effective Date 2019-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
ibuprofen (200 mg)
Inactive Ingredients
starch, corn fd&c yellow no. 6 hypromellose, unspecified ferric oxide red talc polyvinyl alcohol, unspecified propylene glycol stearic acid titanium dioxide fd&c red no. 40 microcrystalline cellulose croscarmellose

Identifiers & Packaging

Pill Appearance
Imprint: Motrin;IB Shape: oval Color: orange Size: 16 mm Score: 1
Marketing Status
nda active Since 2019-07-05

Purpose

Pain reliever/fever reducer

Description

Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug


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 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

■ ake 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

Uses

■ temporarily relieves minor aches and pains due to:

■ headache ■ muscular aches

■ minor pain of arthritis ■ toothache

■ backache ■ the common cold

■ menstrual cramps

■ temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions

■ do not take more than directed

■ the smallest effective dose should be used

adults and children 12 years and older ■ 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 20-25ºC (68-77ºF)

■ avoid high temperatures and excessive heat above 40ºC (104ºF)

■ do not use if pouch is torn or damaged

Inactive Ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Description

Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Do Not Use

■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

■ right before or after heart surgery

Package Labeling:

Questions Or Comments?

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

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

■ 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, or kidney disease

■ you have asthma

■ 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 the 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

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.

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).

Active Ingredient (in Each Caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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


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 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

■ ake 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

Uses

■ temporarily relieves minor aches and pains due to:

■ headache ■ muscular aches

■ minor pain of arthritis ■ toothache

■ backache ■ the common cold

■ menstrual cramps

■ temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions

■ do not take more than directed

■ the smallest effective dose should be used

adults and children 12 years and older ■ 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 20-25ºC (68-77ºF)

■ avoid high temperatures and excessive heat above 40ºC (104ºF)

■ do not use if pouch is torn or damaged

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

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

Package Labeling:

Questions Or Comments? (Questions or Comments?)

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

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

■ 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, or kidney disease

■ you have asthma

■ 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 the 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

If Pregnant Or Breast Feeding, (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.

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 right away. (1-800-222-1222).

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (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


Advanced Ingredient Data


Raw Label Data

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