First Aid Only Ibuprofen

First Aid Only Ibuprofen
SPL v2
SPL
SPL Set ID 6819da97-88bf-3b4e-e053-2991aa0adeaa
Route
ORAL
Published
Effective Date 2016-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Carnauba Wax Magnesium Stearate Sodium Starch Glycolate Type A Potato Stearic Acid Titanium Dioxide Starch, Corn Hypromelloses Silicon Dioxide Ferric Oxide Red Lactose Cellulose, Microcrystalline Polydextrose Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 44;291 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2016-02-01

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 associated with

■ headache ■ toothache ■ backache ■ menstrual cramps

■ common cold ■ muscular aches ■ minor arthritis pain

Temporarily reduces fever.

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 (see Warnings)

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.

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 ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Active Ingredient

Ibuprofen 200 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Other Information

■ read all product information before using

■ store at 68-77°F (20-25°C)

■ avoid excessive heat 40°C (above 104°F)

■ tamper evident sealed packets

■ do not use any opened or torn packets

Inactive Ingredients

carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide

*may contain

Questions Or Comments?

1-800-835-2263

When Using This Product

■ take with food or milk if stomach upset occurs

■ the risk of heart attack or stroke may increase if you use more than directed or longer than directed

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

Ask A Doctor Before Use If

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

■ 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 for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ redness or swelling is present in the painful area

■ any new or unexpected symptoms occur

First Aid Only Ibuprofen Label

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 specifically 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.

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 associated with

■ headache ■ toothache ■ backache ■ menstrual cramps

■ common cold ■ muscular aches ■ minor arthritis pain

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 (see Warnings)

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.

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:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Active Ingredient (Active ingredient)

Ibuprofen 200 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Other Information (Other information)

■ read all product information before using

■ store at 68-77°F (20-25°C)

■ avoid excessive heat 40°C (above 104°F)

■ tamper evident sealed packets

■ do not use any opened or torn packets

Inactive Ingredients (Inactive ingredients)

carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone K30*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide

*may contain

Questions Or Comments? (Questions or comments?)

1-800-835-2263

When Using This Product (When using this product)

■ take with food or milk if stomach upset occurs

■ the risk of heart attack or stroke may increase if you use more than directed or longer than directed

Stomach Bleeding Warning: (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

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

■ 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 for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ redness or swelling is present in the painful area

■ any new or unexpected symptoms occur

First Aid Only Ibuprofen Label

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 specifically 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.

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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