Xpect Ibuprofen

Xpect Ibuprofen
SPL v7
SPL
SPL Set ID 976ba88a-6428-40d1-a2fd-eac64963ba1d
Route
ORAL
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Ferric Oxide Red Sodium Starch Glycolate Type A Corn Stearic Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
ANDA Completed Since 2021-02-27 Until 2025-09-23

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

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

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
Section 50565-1

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.

Section 50566-9

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
Section 50567-7
When using this product
  • take with food or milk if stomach upset occurs
Section 50568-5
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, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug
Section 50569-3
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
Section 50570-1
Do not use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Warnings

Allergy alert: Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: facial swelling, blisters, hives, shock, skin reddening, asthmas (wheezing), rash

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. 

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
Questions?

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

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, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide, 

Principal Display 50 Packets

Compare active ingredient to Advil®†

FULL STRENGTH IBUPROFEN

Active Ingredient:

Ibuprofen

Pain Reliever/Fever Reducer (NSAID)

  • Temporarily relief from pain, fever, and arthritis inflammation
  • Aspirin-free formula 

Xpect® First aid

WORKPLACE READY®

  • Single Dose
  • Tamper Evident 

100 Tablets • 50 Packets (2 Tablets in each Packet) per Box

†This product is not manufactured or distributed by Pfizer, owner of the registered trademark Advil®. 

Principal Display 125 Packets

Compare active ingredient to Advil®†

FULL STRENGTH IBUPROFEN

Active Ingredient:

Ibuprofen

Pain Reliever/Fever Reducer (NSAID)

  • Temporarily relief from pain, fever, and arthritis inflammation
  • Aspirin-free formula

Xpect® First aid

WORKPLACE READY®

  • Single Dose
  • Tamper Evident

250 Tablets • 125 Packets (2 Tablets in each Packet) per Box

†This product is not manufactured or distributed by Pfizer, owner of the registered trademark Advil®.

Activate Ingredient (in Each Tablet)

Ibuprofen USP, 200 mg USP (NSAID)*

*nonsteroidal anti-inflammatory drug


Structured Label Content

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
Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)
When using this product
  • take with food or milk if stomach upset occurs
Section 50568-5 (50568-5)
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, because ibuprofen may decrease this benefit of aspirin
  • taking any other drug
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
Do not use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Purpose

Pain reliever/fever reducer

Warnings

Allergy alert: Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: facial swelling, blisters, hives, shock, skin reddening, asthmas (wheezing), rash

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. 

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
Questions?

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

Other Information (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 (Inactive ingredients)

carnauba wax, colloidal silicon dioxide, corn starch, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide, 

Principal Display 50 Packets (Principal Display - 50 Packets)

Compare active ingredient to Advil®†

FULL STRENGTH IBUPROFEN

Active Ingredient:

Ibuprofen

Pain Reliever/Fever Reducer (NSAID)

  • Temporarily relief from pain, fever, and arthritis inflammation
  • Aspirin-free formula 

Xpect® First aid

WORKPLACE READY®

  • Single Dose
  • Tamper Evident 

100 Tablets • 50 Packets (2 Tablets in each Packet) per Box

†This product is not manufactured or distributed by Pfizer, owner of the registered trademark Advil®. 

Principal Display 125 Packets (Principal Display - 125 Packets)

Compare active ingredient to Advil®†

FULL STRENGTH IBUPROFEN

Active Ingredient:

Ibuprofen

Pain Reliever/Fever Reducer (NSAID)

  • Temporarily relief from pain, fever, and arthritis inflammation
  • Aspirin-free formula

Xpect® First aid

WORKPLACE READY®

  • Single Dose
  • Tamper Evident

250 Tablets • 125 Packets (2 Tablets in each Packet) per Box

†This product is not manufactured or distributed by Pfizer, owner of the registered trademark Advil®.

Activate Ingredient (in Each Tablet) (Activate ingredient (in each tablet))

Ibuprofen USP, 200 mg USP (NSAID)*

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

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