Motrin Ib

Motrin Ib
SPL v1
SPL
SPL Set ID f70c1b68-61c8-b333-e053-6294a90aadaa
Route
ORAL
Published
Effective Date 2017-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Starch, Corn Fd&c Yellow No. 6 Hypromellose, Unspecified Ferric Oxide Red Magnesium Stearate Polydextrose Polyethylene Glycol, Unspecified Propylene Glycol Shellac Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: MOT Shape: oval Color: orange Size: 16 mm Score: 1
Marketing Status
NDA Active Since 2016-09-22

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

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

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

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.

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

Do Not Use

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

• right before or after heart surgery

Other Information

• read all warnings and directions before use

• store at 20-25ºC (68-77ºF)

• avoid high humidity and excessive heat above 40°C (104°F)

• 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

Questions Or Comments?

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

Principal Display Panel

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, 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:

• 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

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

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

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.

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

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

Other Information (Other information)

• read all warnings and directions before use

• store at 20-25ºC (68-77ºF)

• avoid high humidity and excessive heat above 40°C (104°F)

• 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

Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel

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, 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:

• 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

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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