FDA Label for Xpect Ibuprofen

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