Ibuprofen 200

Ibuprofen 200
SPL v3
SPL
SPL Set ID 07edb8d0-2fa8-4b40-e063-6294a90a2fe9
Route
ORAL
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Povidone K30 Sodium Starch Glycolate Type A Potato Fd&c Yellow No. 6 Talc Titanium Dioxide Polyvinyl Alcohol, Unspecified Stearic Acid Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: G2 Shape: oval Color: orange Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2024-05-01

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
  • minor pain of arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • temporarily reduces fever
Purposes

Pain reliever/ fever reducer

Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and older
  • take 1 captet every 4 to 6 hours while symptoms persist • If pain or fever does not respond to 1 captet, 2 captets may be used • do not exceed 6 captets 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 ibuprofen or 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).
  • do not use if neck wrap or foil inner seal is broken or missing
Inactive Ingredients

colloidal silicon dioxide, FD&C Yellow #6, maize starch, polyethylene glycol, polyvinyl alcohol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?

Call 1-877- 770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal Display Panel

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 chances 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
  • 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
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 body • slurred speech • leg swelling
  • pain gets worse or lasts more than10 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,

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.

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 Captet)

Ibuprofen 200 mg (NSAID)

*nonsteroidal anti-inflammatory drug

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
  • minor pain of arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
  • temporarily reduces fever
Purposes

Pain reliever/ fever reducer

Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years and older
  • take 1 captet every 4 to 6 hours while symptoms persist • If pain or fever does not respond to 1 captet, 2 captets may be used • do not exceed 6 captets 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 ibuprofen or 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
  • store between 20 – 25°C (68 – 77°F).
  • do not use if neck wrap or foil inner seal is broken or missing
Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, FD&C Yellow #6, maize starch, polyethylene glycol, polyvinyl alcohol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-877- 770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal Display Panel (Principal display panel)

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 chances 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)
  • 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
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 body • slurred speech • leg swelling
  • pain gets worse or lasts more than10 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

Active Ingredient (in Each Captet) (Active ingredient (in each captet))

Ibuprofen 200 mg (NSAID)

*nonsteroidal anti-inflammatory drug

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

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