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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

Allergy alert: Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
Hives
Facial swelling
Asthma (wheezing)
Shock
Skin reddening
Rash
Blisters
If 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
Do not use
If you ever had an allergic reaction to any other pain reliever/fever reducer
Right before or after heart surgery
Ask a doctor before use if:
The 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 are taking a diuretic
Ask a doctor or pharmacist before use if are:
Taking any other drug containing an NSAID (prescription or nonprescription)
Taking a blood thinning (anticoagulant) or steroid drug
Under a doctor’s care for any serious condition
Taking any another drug
When using this product:
Take with food or milk if stomach upset occurs
Long term continuous use may increase the risk of heart attack or stroke.
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 more than 10 days
Fever gets worse or lasts more than 3 days
You have difficulty swallowing
It feels like the pill is stuck in your throat
Redness or swelling is present in the painful area
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 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.

Purpose

Active ingredient (in each tablet)
Ibuprofen, USP 200mg (NSAID)*……………………………….Pain reliever/Fever reducer
*Nonsteroidal anti-inflammatory drug

Uses

Temporarily relieves fever and minor aches and pains associated with:
Muscular aches
Backache
Menstrual cramps
Headache
Toothache
Arthritis
Common cold

Directions

Do not take 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: Take 1 tablet every 4 to 6 hours while symptoms occur; if pain or fever does not respond to 1 tablet, 2 tablets may be used, but do not exceed 6 tablets in 24 hours, unless directed by doctor
Children under 12 years of age: Ask a doctor

Other Information

Do not use if packet is torn, cut, or opened
Store at room temperature
Avoid excessive heat above 40C (104F)
Single Dose
Tamper evident
Non-Drowsy
Questions? 1-877-973-2811 Monday – Friday 8:00AM – 5:00PM
250 Tablets/2 Tablets per Packet
Product #111999

Ibuprofen, USP 200mg (NSAID)*……………………………….Pain reliever/Fever reducer
*Nonsteroidal anti-inflammatory drug

Anhydrous lactose*, carnauba wax*, colloidal silicon dioxide, corn starch*, croscarmellose sodium*, FD&C #2*, FD&C Red #40*, FD&C #6*, Hypromellose*, lactose monohydrate*, magnesium stearate*, maltodextrin*, medium chain triglycerides*, microcrystalline cellulose*, polydextrose, polyethylene glycol*, polyvinyl alcohol*, povidone*, pregelatinized starch*, red iron oxide, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide, triacetin*
*may contain ingredient

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

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
POLYDEXTROSE (UNII: VH2XOU12IE)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
May contain	SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
May contain	CARNAUBA WAX (UNII: R12CBM0EIZ)
May contain	CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
May contain	FD&C RED NO. 40 (UNII: WZB9127XOA)
May contain	FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
May contain	FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
May contain	HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
May contain	LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
May contain	MAGNESIUM STEARATE (UNII: 70097M6I30)
May contain	MALTODEXTRIN (UNII: 7CVR7L4A2D)
May contain	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
May contain	MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
May contain	POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
May contain	POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
May contain	POVIDONE (UNII: FZ989GH94E)
May contain	STARCH, CORN (UNII: O8232NY3SJ)
May contain	SODIUM LAURYL SULFATE (UNII: 368GB5141J)
May contain	SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
May contain	STEARIC ACID (UNII: 4ELV7Z65AP)
May contain	TALC (UNII: 7SEV7J4R1U)
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: 42961-203-02	250 in 1 BOX	02/27/2021
1	NDC: 42961-203-01	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)