Ibuprofen

Ibuprofen
SPL v8
SPL
SPL Set ID 8fc65767-1783-4f7f-8680-9e43ba4d5481
Route
ORAL
Published
Effective Date 2022-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Hypromellose, Unspecified Ferric Oxide Red Polydextrose Polyethylene Glycol, Unspecified Sodium Starch Glycolate Type A Potato Stearic Acid Carnauba Wax Starch, Corn Anhydrous Lactose Magnesium Stearate Silicon Dioxide Microcrystalline Cellulose Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;291 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Completed Since 2017-05-02 Until 2027-06-18

Description

Ibuprofen 200 mg (NSAID 1 nonsteroidal anti-inflammatory drug )

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer

Description

Ibuprofen 200 mg (NSAID 1 nonsteroidal anti-inflammatory drug )

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis

  • temporarily reduces fever
Section 42229-5

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Advil tablets.

Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

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 does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor

  • store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Allergy Alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Other Information
  • 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

Questions Or Comments?

call toll-free 1-877-507-6516 (M-F 8 AM-4:30PM CST)

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN

Advil*

Ibuprofen

Pain Reliever / Fever Reducer

(NSAID), 200mg

2 TABLETS PER POUCH

When Using This Product
  • take with food or milk if stomach upset occurs
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
Ask A Doctor Before Use If
  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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
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

  • you have symptoms of heart problems or stroke:

  • chest pain
  • trouble breathing
  • weakness in one part or side of the body
  • slurred speech
  • leg swelling

  • 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

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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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.

Active Ingredient (in Each Tablet)

Ibuprofen 200 mg (NSAID

1 nonsteroidal anti-inflammatory drug
)

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

Structured Label Content

Uses (USES)
  • temporarily relieves minor aches and pains due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis

  • temporarily reduces fever
Section 42229-5 (42229-5)

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Advil tablets.

Distributed by: Lil’ Drug Store Products, Inc., Cedar Rapids, IA 52404

Purpose (PURPOSE)

Pain reliever/Fever reducer

Directions (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 does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor

  • store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Allergy Alert (Allergy alert)

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Other Information (OTHER INFORMATION)
  • 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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

call toll-free 1-877-507-6516 (M-F 8 AM-4:30PM CST)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

COMPARE TO THE ACTIVE INGREDIENTS IN

Advil*

Ibuprofen

Pain Reliever / Fever Reducer

(NSAID), 200mg

2 TABLETS PER POUCH

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning (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
Ask A Doctor Before Use If (Ask a doctor before use if)
  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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
Stop Use and Ask A Doctor If (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

  • you have symptoms of heart problems or stroke:

  • chest pain
  • trouble breathing
  • weakness in one part or side of the body
  • slurred speech
  • leg swelling

  • 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 (If pregnant or breast-feeding)

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. (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 (1-800-222-1222).

Heart Attack and Stroke Warning (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.

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

Ibuprofen 200 mg (NSAID

1 nonsteroidal anti-inflammatory drug
)

Ask A Doctor Or Pharmacist Before Use If You Are (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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)