UNISHIELD IBUPROFEN- ibuprofen tablet, coated

Unishield Ibuprofen by

Drug Labeling and Warnings

Unishield Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Unishield, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

PURPOSE

Purpose

Pain reliever/fever reducer

INDICATIONS & 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.

WARNINGS

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.

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

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

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

WHEN USING

When using this product

■ take with food or milk if stomach upset occurs

STOP USE

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

PREGNANCY 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.

DOSAGE & 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.

OTHER SAFETY 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 INGREDIENT

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

Questions or comments? 800-480-5855

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

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

INGREDIENTS AND APPEARANCE

UNISHIELD IBUPROFEN 
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-1003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POVIDONE (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	brown (Reddish)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	G;2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49314-1003-3	50 in 1 BOX	03/01/2021
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079174	03/01/2021

UNISHIELD IBUPROFEN 
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49314-0993
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYDEXTROSE (UNII: VH2XOU12IE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;291
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49314-0993-3	50 in 1 BOX	03/01/2021
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075010	03/01/2021

Labeler - Unishield (790677053)

Registrant - Unifirst First Aid Corporation (832947092)