Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 16b751a9-2f33-4303-b75f-ca0c012a212d
Route
ORAL
Published
Effective Date 2015-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Ferric Oxide Red Magnesium Stearate Cellulose, Microcrystalline Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G2 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-12-02

Description

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

Purpose

Pain reliever/Fever reducer


Medication Information

Purpose

Pain reliever/Fever reducer



Dosage and Administration
  • 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
  • children under 12 years: ask a doctor
Description

Ibuprofen 200 mg (NSAID)* *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 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.



Warnings

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.



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
  • each tablet contains: sodium 22 mg
  • read all warnings and directions before use
  • Keep carton or card
  • store at 20 - 25°C (68 - 77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, magnesium stearate,microcrystalline cellulose, talc, titanium dioxide



Questions Or Comments

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com



Principal Display Panel

NDC 70005-009-25

SEE NEW WARNINGS AND DIRECTIONS

We Care

For Good Health

COMPARE TO ACTIVE INGREDIENT IN Advil®* CAPLETS

TO OPEN PUSH IN TAB AND PULL OUT

Ibuprofen 200 mg

Pain Reliever/Fever Reducer (NSAID)





  • Headache
  • Toothache
  • Minor Pain of Arthritis
  • Fever

  • Muscularache
  • Menstrual Cramps

Ibuprofen

*This product is not manufactured or distributed by Pfizer Healthcare, owner of the registered trademark of Advil®* tablets.

25 Pouches of 2 Coated Tablets







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 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
  • 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, 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
  • redness or swelling is present in the painful area
  • any new symptoms appear

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



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

Dosage and Administration (34068-7)
  • 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
  • children under 12 years: ask a doctor
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



Warnings

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.



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)
  • each tablet contains: sodium 22 mg
  • read all warnings and directions before use
  • Keep carton or card
  • store at 20 - 25°C (68 - 77°F)
  • avoid excessive heat above 40°C (104°F)

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, magnesium stearate,microcrystalline cellulose, talc, titanium dioxide



Questions Or Comments (Questions or Comments)

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com



Principal Display Panel

NDC 70005-009-25

SEE NEW WARNINGS AND DIRECTIONS

We Care

For Good Health

COMPARE TO ACTIVE INGREDIENT IN Advil®* CAPLETS

TO OPEN PUSH IN TAB AND PULL OUT

Ibuprofen 200 mg

Pain Reliever/Fever Reducer (NSAID)





  • Headache
  • Toothache
  • Minor Pain of Arthritis
  • Fever

  • Muscularache
  • Menstrual Cramps

Ibuprofen

*This product is not manufactured or distributed by Pfizer Healthcare, owner of the registered trademark of Advil®* tablets.

25 Pouches of 2 Coated Tablets







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 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)
  • 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, 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
  • redness or swelling is present in the painful area
  • any new symptoms appear

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



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)