Ibuprofen Tablets

Ibuprofen Tablets
SPL v7
SPL
SPL Set ID 5398f5b7-a9a6-4f7e-a06c-e524b9939562
Route
ORAL
Published
Effective Date 2020-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Ferric Oxide Red Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone K30 Sodium Starch Glycolate Type A Potato Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G2 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2020-03-12

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

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

Drug Facts

Section 50565-1

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)

Section 53414-9

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.

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 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
  • children under 12 years: ask a doctor
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
  • read all warnings and directions before use. Keep carton.
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients

Colloidal silicon dioxide, corn starch, iron oxide red, polyethylene glycol, polyvinyl alcohol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide.

Questions Or Comments?

1-888-309-9030

Principal Display Panel



COMPARE TO ACTIVE INGREDIENT OF

ADVIL® TABLETS*

Ibuprofen

• Ibuprofen Tablets USP, 200 mg

Pain reliever / Fever reducer (NSAID)

When Using This Product
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stomach Bleeding Warning

This product contains a nonsteroidal anti-inflammatory drug (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 stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
  • 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
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in the painful area
  • any new symptoms appear
Heart Attack and Stroke Warning

NSAID's except aspirin increases 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)*

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
  • 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)

Drug Facts

Section 50565-1 (50565-1)

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)

Section 53414-9 (53414-9)

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.

Purpose

Pain reliever/fever reducer

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 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
  • children under 12 years: ask a doctor
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)
  • read all warnings and directions before use. Keep carton.
  • store between 20°-25°C (68°-77°F)
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, corn starch, iron oxide red, polyethylene glycol, polyvinyl alcohol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide.

Questions Or Comments? (Questions or comments?)

1-888-309-9030

Principal Display Panel (PRINCIPAL DISPLAY PANEL)



COMPARE TO ACTIVE INGREDIENT OF

ADVIL® TABLETS*

Ibuprofen

• Ibuprofen Tablets USP, 200 mg

Pain reliever / Fever reducer (NSAID)

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stomach Bleeding Warning (Stomach bleeding warning)

This product contains a nonsteroidal anti-inflammatory drug (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 stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
  • 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
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • stomach pain or upset gets worse or lasts
  • redness or swelling is present in the painful area
  • any new symptoms appear
Heart Attack and Stroke Warning (Heart attack and stroke warning)

NSAID's except aspirin increases 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)*

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)