Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 523bef75-c20a-4cfd-8d31-725bafae6df8
Route
ORAL
Published
Effective Date 2012-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ibuprofen (200 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Dextrose Monohydrate Hypromelloses Ferric Oxide Red Lactose Monohydrate Egg Phospholipids Maltodextrin Povidones Carboxymethylcellulose Sodium Sodium Starch Glycolate Type A Corn Stearic Acid Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: G2 Shape: round Color: brown Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2012-07-05

Description

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

Purpose

Pain Reliever/ Fever Reducer


Medication Information

Purpose

Pain Reliever/ Fever Reducer

Description

Ibuprofen USP, 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
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 an seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID) which may cause severe stomach bleeding. The chance are higher if you:

  • are age 60 or oder
  • have had stomach ulders or bleeding problems
  • take blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks everyday while using this prdouct
  • take more or for a longer time than directed.
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
  • if you ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Product Label
Ibuprofen tablets 200 mg tablets
Other Information
  • store between 20o- 25o C (68o- 77o F)
  • read all warnings and directions before use. Keep carton
  • do not use if imprinted foil under cap is broken or missing
  • †This product is not manufactured or distributed by Pfizer consumer healthcare, owner of the registered trademark Advil®
Inactive Ingredients

colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin

Questions Or Comments?

Call: 1-503-639-6300 Monday- Friday 9AM-5PM PST

Principal Display Panel

Compare to the active ingredient in ADVIL®†

SEE NEW WARNINGS INFORMATION

Ibuprofen Tablets

Pain Reliever/ Fever Reducer (NSAID)*

Proudly distributed by Western family foods, Inc.

PO Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Manufactured by:

Granules India limited

Madhapur, Hyderabad- 500081, India

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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.
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, or kidney disease
  • you have 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 bet better
    • Pain gets worse or last more than 10 days
    • Fever gets worse or last 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 druing the last 3 months of pegnancy unless defintely 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)

Active Ingredient (in Each Tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking aspirin to prevent 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
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 an seek medical help right away.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID) which may cause severe stomach bleeding. The chance are higher if you:

  • are age 60 or oder
  • have had stomach ulders or bleeding problems
  • take blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks everyday while using this prdouct
  • take more or for a longer time than directed.
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 ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Product Label
Ibuprofen tablets 200 mg tablets
Other Information (Other information)
  • store between 20o- 25o C (68o- 77o F)
  • read all warnings and directions before use. Keep carton
  • do not use if imprinted foil under cap is broken or missing
  • †This product is not manufactured or distributed by Pfizer consumer healthcare, owner of the registered trademark Advil®
Inactive Ingredients

colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide, and triacetin

Questions Or Comments? (Questions or comments?)

Call: 1-503-639-6300 Monday- Friday 9AM-5PM PST

Principal Display Panel

Compare to the active ingredient in ADVIL®†

SEE NEW WARNINGS INFORMATION

Ibuprofen Tablets

Pain Reliever/ Fever Reducer (NSAID)*

Proudly distributed by Western family foods, Inc.

PO Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Manufactured by:

Granules India limited

Madhapur, Hyderabad- 500081, India

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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.
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, or kidney disease
  • you have 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 bet better
    • Pain gets worse or last more than 10 days
    • Fever gets worse or last 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 druing the last 3 months of pegnancy unless defintely 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)

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 If You Are (Ask a doctor or pharmacist before use if you are)
  • taking aspirin to prevent 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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