Unishield Ibuprofen

Unishield Ibuprofen
SPL v5
SPL
SPL Set ID b9e2e2ba-e2ad-eace-e053-2995a90aed35
Route
ORAL
Published
Effective Date 2021-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;291 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2021-03-01

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

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.

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.

Indications and Usage

Uses

Temporarily relieves minor aches and pains associated with

■ headache ■ toothache ■ backache ■ menstrual cramps

■ common cold ■ muscular aches ■ minor arthritis pain

Temporarily reduces fever.

Dosage and Administration

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:

Ask a doctor.

Description

Drug Facts

Section 42229-5

Drug Facts

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 50566-9

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 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

Section 50567-7

When using this product

■ take with food or milk if stomach upset occurs

Section 50568-5

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

Section 50569-3

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, kidney disease, asthma or had a stroke

■ 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 51727-6

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

Section 53413-1

Questions or comments? 800-480-5855

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Section 60561-8

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

Unishield Ibuprofen Label

Unishield

Ibuprofen 200 mg

Pain Reliever/Fever Reducer (NSAID)

100 Tablets/ 1 Tablet Per Packet

Pull To Open

This Package is for Households without Young Children.

• Temporary relief from pain, fever and inflammation

• Soothes muscle aches and minor arthritis pain

Compare active ingredient to:

Advil®

Registered Trademark of Pfizer Consumer Healthcare

Tamper Evident Unit Dose Packets


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves minor aches and pains associated with

■ headache ■ toothache ■ backache ■ menstrual cramps

■ common cold ■ muscular aches ■ minor arthritis pain

Temporarily reduces fever.

Dosage and Administration (34068-7)

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:

Ask a doctor.

Warnings and Precautions (34071-1)

Warnings

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.

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.

Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

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 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

Section 50567-7 (50567-7)

When using this product

■ take with food or milk if stomach upset occurs

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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, kidney disease, asthma or had a stroke

■ 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 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions or comments? 800-480-5855

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

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

Unishield Ibuprofen Label

Unishield

Ibuprofen 200 mg

Pain Reliever/Fever Reducer (NSAID)

100 Tablets/ 1 Tablet Per Packet

Pull To Open

This Package is for Households without Young Children.

• Temporary relief from pain, fever and inflammation

• Soothes muscle aches and minor arthritis pain

Compare active ingredient to:

Advil®

Registered Trademark of Pfizer Consumer Healthcare

Tamper Evident Unit Dose Packets


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)