Ibuprofen 50ct, Casey's 4good

Ibuprofen 50ct, Casey's 4good
SPL v2
SPL
SPL Set ID 04b3ad8b-bdf9-47f3-e063-6294a90ac350
Route
ORAL
Published
Effective Date 2023-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G2 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
ANDA Completed Since 2023-08-01 Until 2027-04-01

Description

​Drug facts

Purpose

Purpose Pain reliever/fever reducer


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Description

​Drug facts

Uses

Uses

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

Warnings

Directions

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and older:
  • 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
Drug Facts

​Drug facts

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° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients

Inactive ingredients

colloidal silicon dioxide, iron oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?

Questions or comments? Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Ask A Doctor Before Use

Ask a doctor before use if

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
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
Stop Use and Ask A Doctor If

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • have bloody or black stools
  • feel faint
  • 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 the 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
If Pregnant Or Breast Feeding

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.

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.

Ibuprofen 50ct, Casey's 4good Tm

SEE NEW WARNINGS

Ibuprofen

Tablets USP, 200 mg (NSAID)*


Pain Reliever/Fever Reducer

Compare to the

active ingredient in

Advil Tablets**

[tablet image]

actual

size

[casey's logo]

50 COATED TABLETS

Active Ingredient (in Each Tablet)

Active ingredient (in each tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use

Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug

Structured Label Content

Uses

Uses

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

Purpose

Pain reliever/fever reducer

Warnings

Warnings

Directions

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and older:
  • 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)

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Drug Facts (Drug facts)

​Drug facts

Allergy Alert (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)

Other information

  • store between 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
  • avoid excessive heat above 40°C (104°F)
Inactive Ingredients (Inactive ingredients)

Inactive ingredients

colloidal silicon dioxide, iron oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

Questions or comments? Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Ask A Doctor Before Use (Ask a doctor before use)

Ask a doctor before use if

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
When Using This Product (When using this product)

When using this product

  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning (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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • have bloody or black stools
  • feel faint
  • 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 the 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
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 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.

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)

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.

Ibuprofen 50ct, Casey's 4good Tm (Ibuprofen 50ct, Casey's 4good TM)

SEE NEW WARNINGS

Ibuprofen

Tablets USP, 200 mg (NSAID)*


Pain Reliever/Fever Reducer

Compare to the

active ingredient in

Advil Tablets**

[tablet image]

actual

size

[casey's logo]

50 COATED TABLETS

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

Active ingredient (in each tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

Ask a doctor or pharmacist before use if you are

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

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