Xpect Ibuprofen Tablet
FDA Label NDC 42961-203

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corporation for the product Xpect Ibuprofen (NDC 42961-203). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding warnings, purpose, uses, directions, other information, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

Otc - 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.

Package Label.Principal Display Panel

Xpect Ibuprofen (111919 Xp Ibuprofen Wrapper V2)

Xpect Ibuprofen (111919 Xp Ibuprofen Wrapper V2)

Xpect Ibuprofen (111919 Xp Ibuprofen Wrapper V2)

Xpect Ibuprofen (111919 Xp Ibuprofen Wrapper V2)

* Please review the disclaimer below.