XPECT IBUPROFEN- ibuprofen tablet

Xpect Ibuprofen by

Drug Labeling and Warnings

Xpect Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation, L.N.K. International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Activate ingredients (in each tablet)

Ibuprofen, USP (NSAID)* 200 mg
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to: muscular aches, backache, toothache, menstrual cramps, headache, the common cold, minor pain of arthritis, temporarily reduces fever

Warnings

Allergy alert: Ibuprofen may cause 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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• take more or for a longer time than directed
• take a blood thinning (anticoagulant) or steroid drug
• are age 60 or older
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• have had stomach ulcers or bleeding problems
• have 3 or more alcoholic drinks every day while using this product 

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

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

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

Ask a doctor or pharmacist before use if you are

• under a doctor's care for any serious condition
• taking aspirin for heart attack or stroke, becuase ibuprofen may decrease this benefit of aspirin
• taking any other drug

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, have bloody or black stools, vomit blood, 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
• redness or swelling is present in the painful area
• any new symptoms appear

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 becuse 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.

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 dose 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 information

• do not use if packet is torn, cut, or opened
• Store between 20°-25°C (68°-77°F)
• avoid excessive heat above 40°C (104°F)

Inactive ingredients

carnauba wax*, colloidal silicon dioxide, corn starch*, hypromellose, lactose anhydrous*, lactose monohydrate (derived from milk)*, magnesium stearate*, maize starch*,microcrystalline cellulose*, polydextrose*, polyethylene glycol*, povidone k-30*, pregelatinized starch*, purified water*, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin*

*may contain ingredient

Questions?

1-877-973-2811 Monday-Friday 8:00am-5:00pm

Principal Display Panel - Wrapper

FULL STRENGTH IBUPROFEN

Principal Display Panel - 100 count Box

FULL STRENGTH IBUPROFEN

Pain Reliever/Fever Reducer

• Compare active ingredient to Advil®
• Temporary relief from pain, fever, and arthritis inflammation
• Aspirin-free formula

Xpect® First aid

Active Ingredients: Ibuprofen (NSAID)

WORKPLACE READY™

• Single Dose
• Tamper Evident
• Non-Drowsy

100 Tablets 2 Tablets per Packet

Principal Display Panel - 250 count Box

FULL STRENGTH IBUPROFEN

Pain Reliever/Fever Reducer

• Compare active ingredient to Advil®
• Temporary relief from pain, fever, and arthritis inflammation
• Aspirin-free formula

Xpect® First aid

Active Ingredients: Ibuprofen (NSAID)

WORKPLACE READY™

• Single Dose
• Tamper Evident
• Non-Drowsy

250 Tablets 2 Tablets per Packet

INGREDIENTS AND APPEARANCE

XPECT IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-203
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	CARNAUBA WAX (UNII: R12CBM0EIZ)
May contain	STARCH, CORN (UNII: O8232NY3SJ)
May contain	HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
May contain	ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
May contain	LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
May contain	MAGNESIUM STEARATE (UNII: 70097M6I30)
May contain	MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
May contain	POLYDEXTROSE (UNII: VH2XOU12IE)
May contain	POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
May contain	POVIDONE K30 (UNII: U725QWY32X)
May contain	WATER (UNII: 059QF0KO0R)
May contain	TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-203-06	250 in 1 BOX	02/27/2021
1	NDC: 42961-203-04	2 in 1 PACKET; Type 1: Convenience Kit of Co-Package
2	NDC: 42961-203-05	100 in 1 BOX	12/31/2022
2	NDC: 42961-203-04	2 in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079174	02/27/2021

Labeler - Cintas Corporation (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
L.N.K. International		832867837	manufacture(42961-203)