Dye Free Ibuprofen

Dye Free Ibuprofen
SPL v1
SPL
SPL Set ID ba106f6f-2c6b-4c98-a10e-d27622b08b25
Route
ORAL
Published
Effective Date 2017-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Hypromellose, Unspecified Triacetin Magnesium Stearate Stearic Acid Starch, Corn Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Povidone, Unspecified Anhydrous Lactose Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;438 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 1999-03-01

Description

Drug Facts

Purpose

Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug


Medication Information

Purpose

Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug

Description

Drug Facts

Uses

_ temporarily relieves minor aches and pains due to:

_ backache _ muscular aches _ minor pain of arthritis

_ headache _ menstrual cramps

_ toothache _ the common cold

_ temporarily reduces fever

Drug Facts (continued)

Section 42229-5

Drug Facts

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.

Drug Facts (continued)

These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Active In

Ibuprofen USP, 200 mg (NSAID)*

Directions

_ do not take more than directed

_ the smallest effective dose should be used

_ adults and children 12 years and over: 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

Drug Facts (continued)

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

_ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS   OPENED OR BLISTER IS TORN OR BROKEN

_ store between 20°-25°C (68°-77°F)

_ avoid excessive heat 40°C (104°F)

_ use by expiration date on package

Inactive Ingredients

corn starch, colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin

Questions Or Comments?

1-800-901-2420

Dist. by Breeden Brothers, LLC

Nashville, TN 37219

Principal Display Panel

b+b

better by giving

When Using This Product

_ take with food or milk if stomach upset occurs

Ask A Doctor Before Use If

_ 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

_ you have problems or serious side effects from taking pain relievers or fever reducers

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 _ slurred speech

_ leg swelling _ trouble breathing

_ weakness in one part or side of body

_ pain gets worse or lasts more than 10 days

_ fever gets worse or lasts more than 3 days

_ any new symptoms appear

_ redness or swelling is present in the painful area

Drug Facts (continued)

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 (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If You Are

_ under a doctor's care for any serious condition

_ taking any other drug

Drug Facts (continued)

_ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin


Structured Label Content

Uses

_ temporarily relieves minor aches and pains due to:

_ backache _ muscular aches _ minor pain of arthritis

_ headache _ menstrual cramps

_ toothache _ the common cold

_ temporarily reduces fever

Drug Facts (continued)

Section 42229-5 (42229-5)

Drug Facts

Purpose

Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug

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.

Drug Facts (continued)

These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Active In (Active in)

Ibuprofen USP, 200 mg (NSAID)*

Directions

_ do not take more than directed

_ the smallest effective dose should be used

_ adults and children 12 years and over: 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

Drug Facts (continued)

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)

_ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS   OPENED OR BLISTER IS TORN OR BROKEN

_ store between 20°-25°C (68°-77°F)

_ avoid excessive heat 40°C (104°F)

_ use by expiration date on package

Inactive Ingredients (Inactive ingredients)

corn starch, colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin

Questions Or Comments? (Questions or comments?)

1-800-901-2420

Dist. by Breeden Brothers, LLC

Nashville, TN 37219

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

b+b

better by giving

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)

_ 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

_ you have problems or serious side effects from taking pain relievers or fever reducers

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 _ slurred speech

_ leg swelling _ trouble breathing

_ weakness in one part or side of body

_ pain gets worse or lasts more than 10 days

_ fever gets worse or lasts more than 3 days

_ any new symptoms appear

_ redness or swelling is present in the painful area

Drug Facts (continued)

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 (1-800-222-1222) right away.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

_ under a doctor's care for any serious condition

_ taking any other drug

Drug Facts (continued)

_ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin


Advanced Ingredient Data


Raw Label Data

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