Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 17331594-e332-4ada-9b6b-3805d92f0e98
Route
ORAL
Published
Effective Date 2014-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Fd&c Yellow No. 6 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Sodium Starch Glycolate Type A Potato Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: IBU200 Shape: round Color: orange Size: 17 mm Score: 1
Marketing Status
ANDA Active Since 2014-12-30

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Ibuprofen USP, 200mg (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

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

Do Not Use

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

after heart surgery

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.

Active Ingredient

Ibuprofen USP, 200mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Other Information

store between 20-25 °C (68-77° F). ■ Read all warnings and directions before use Do not use if

seal under bottle cap is broken or missing.

Inactive Ingredients

Colloidal silicon dioxide, corn starch, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin

Questions Or Comments?

Call 1-888-952-0050

Monday through Friday 9AM – 5PM EST

When Using This Product

take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stomach Bleeding Warning

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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

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 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).

Package/label Principal Display Panel
Ask A Doctor Or Pharmacist Before Use If You Are

■ taking aspirin to prevent 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

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

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

Allergy Alert (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.

Active Ingredient (Active ingredient)

Ibuprofen USP, 200mg (NSAID)**

**nonsteroidal anti-inflammatory drug

Other Information (Other information)

store between 20-25 °C (68-77° F). ■ Read all warnings and directions before use Do not use if

seal under bottle cap is broken or missing.

Inactive Ingredients

Colloidal silicon dioxide, corn starch, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin

Questions Or Comments? (Questions or Comments?)

Call 1-888-952-0050

Monday through Friday 9AM – 5PM EST

When Using This Product (When using this product)

take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stomach Bleeding Warning (Stomach bleeding warning)

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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

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 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

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Package/label Principal Display Panel (Package/Label Principal Display Panel)
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

■ taking aspirin to prevent 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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