ibuprofen, 200 mg

ibuprofen, 200 mg
SPL v13
SPL
SPL Set ID 4d554163-43f3-4fdc-86a2-0d64dec85b4f
Route
oral
Published
Effective Date 2010-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
ibuprofen (200 mg)
Inactive Ingredients
polyethylene glycol povidone silicon dioxide stearic acid titanium dioxide triacetin powdered cellulose starch, corn hypromelloses lactose magnesium stearate polydextrose

Identifiers & Packaging

Pill Appearance
Imprint: 44;352 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
anda active Since 2010-02-17

Purpose

Pain reliever/fever reducer

Description

Ibuprofen USP (NSAID*) 200mg *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: shock,  facial swelling,  asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.



Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 thinner (anticoagulant) or steroid drug, take other drugs containing 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

Active Ingredient

Ibuprofen USP (NSAID*) 200mg

*nonsteroidal anti-inflammatory drug

Uses



temporarily relieves minor aches and pains due to:



the common cold



headache



toothache



muscular aches



backache



minor pain of arthritis



menstrual cramps temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions

do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.



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: Do not give to children under 12 years of age.

Other Information

Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets

Inactive Ingredients

cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

Description

Distributed by GENUINE FIRST AID

600 Cleveland Str Suite 400, Clearwater, FL 33755

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 50569-3

Ask a doctor before use if  stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

Section 50570-1



Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer,  right before or after heart surgery.

Section 51945-4

IBUPROFEN 2 Tablets

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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

When Using This Product

take with food or milk if stomach upset occurs

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 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

Ask A Doctor Before Use If You Are:

taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; 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: shock,  facial swelling,  asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.



Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 thinner (anticoagulant) or steroid drug, take other drugs containing 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

Active Ingredient (Active Ingredient (in each tablet))

Ibuprofen USP (NSAID*) 200mg

*nonsteroidal anti-inflammatory drug

Uses



temporarily relieves minor aches and pains due to:



the common cold



headache



toothache



muscular aches



backache



minor pain of arthritis



menstrual cramps temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions

do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.



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: Do not give to children under 12 years of age.

Other Information (Other information)

Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets

Inactive Ingredients

cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

Description (34089-3)

Distributed by GENUINE FIRST AID

600 Cleveland Str Suite 400, Clearwater, FL 33755

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 50569-3 (50569-3)

Ask a doctor before use if  stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

Section 50570-1 (50570-1)



Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer,  right before or after heart surgery.

Section 51945-4 (51945-4)

IBUPROFEN 2 Tablets

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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

When Using This Product (When using this product)

take with food or milk if stomach upset occurs

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 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

Ask A Doctor Before Use If You Are: (Ask a doctor before use if you are:)

taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug


Advanced Ingredient Data


Raw Label Data

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