OTC Medication Information: Xpect Ibuprofen

XPECT IBUPROFEN- ibuprofen tablet
Cintas Corporation

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

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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

box-100box-100

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

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(click image for full-size original)
XPECT IBUPROFEN
ibuprofen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-203
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FERRIC OXIDE RED
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color red Score no score
Shape ROUND Size 7mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42961-203-06 250 PACKET100 PACKET in 1 BOX contains a PACKET (42961-203-04)
1 NDC:42961-203-05 250 PACKET100 PACKET in 1 BOX contains a PACKET (42961-203-04)
1 NDC:42961-203-04 2 TABLET in 1 PACKET This package is contained within a BOX (42961-203-06) and a BOX (42961-203-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079174 02/27/2021
Labeler — Cintas Corporation (056481716)
Registrant — Cintas Corporation (056481716)
Establishment
Name Address ID/FEI Operations
L.N.K. International 832867837 manufacture (42961-203)

Revised: 12/2022 Cintas Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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