SPL v1
SPL
SPL Set ID 9e71f1c1-5272-4209-8974-6c525b141155
Route
ORAL
Published
Effective Date 2024-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;291 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2024-08-19

Description

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

Purpose

Pain reliever / fever reducer


Medication Information

Purpose

Pain reliever / fever reducer

Description

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

Uses:

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • the common cold
  • backache
  • minor pain of arthritis
  • temporarily reduces fever
  • toothache
  • menstrual cramps
Section 42229-5

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

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

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

Directions

Adults and children 12 years and over:

  • do not take more than directed
  • the smallest effective dose should be used
  • 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
Other Information
  • read all product information before using
  • tamper evident. Do not use if packet is torn or opened
  • store between 68°-77°F (20°-25°C)
  • avoid excessive heat 104°F (40°C)
  • use by expiration date on package
Inactive Ingredients

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

When Using This Product:
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If:
  • 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
    • weakness in one part or side of body
    • leg swelling
    • slurred speech
    • trouble breathing
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear
  • redness or swelling is present in the painful area
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 specifically 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.

Active Ingredient (in Each Tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Principal Display Panel – 250 Tablet Box Label

2525

Flex-Prin

Ibuprofen

Compare to Advil

  • Fast Acting Fever Reducer
  • Relieves Headaches & Joint Pains
  • Compare to Advil

The Provision

First Aid

Line™

BY WILDMAN

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:

Temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • the common cold
  • backache
  • minor pain of arthritis
  • temporarily reduces fever
  • toothache
  • menstrual cramps
Section 42229-5 (42229-5)

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

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

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

Purpose

Pain reliever / fever reducer

Directions (DIRECTIONS)

Adults and children 12 years and over:

  • do not take more than directed
  • the smallest effective dose should be used
  • 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
Other Information (OTHER INFORMATION)
  • read all product information before using
  • tamper evident. Do not use if packet is torn or opened
  • store between 68°-77°F (20°-25°C)
  • avoid excessive heat 104°F (40°C)
  • use by expiration date on package
Inactive Ingredients

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

When Using This Product: (When using this product:)
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If: (Ask a doctor before use if:)
  • 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
    • weakness in one part or side of body
    • leg swelling
    • slurred speech
    • trouble breathing
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear
  • redness or swelling is present in the painful area
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 specifically 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.

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

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Principal Display Panel – 250 Tablet Box Label

2525

Flex-Prin

Ibuprofen

Compare to Advil

  • Fast Acting Fever Reducer
  • Relieves Headaches & Joint Pains
  • Compare to Advil

The Provision

First Aid

Line™

BY WILDMAN

Ask A Doctor Or Pharmacist Before Use If You Are: (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

All Sections (JSON)