Clear Choice Ibuprofen

Clear Choice Ibuprofen
SPL v2
SPL
SPL Set ID 20bde9bd-7b13-4be4-9cba-ebc10c834a7a
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
Anhydrous Lactose Carnauba Wax Silicon Dioxide Hypromelloses Ferric Oxide Red Magnesium Stearate Cellulose, Microcrystalline Polydextrose Polyethylene Glycols Povidones Sodium Lauryl Sulfate Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: IBU200 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2012-10-09

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Ibuprofen USP, 200mg (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 and seek medical help right away.

Stomach bleeding warning

: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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
Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor ( see Warnings)
  • 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 have ever had an allergic reaction to other pain reliever/fever reduce

right before or after heart surgery

Package Label

Clear Choice

IBUPROFEN

MODERN PAIN MEDICINE

PAIN AND FEVER RELIEF

CONTAINS NO ASPIRIN

CAFFEINE FREE

Compare to Advil (R)

100 Tablets

200 mg each

This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Advil (R)

Manufactured for: A.N.I. Toledo, OH 43623 CODE 27541

Lot No.:

Exp. Date:







Other Information
  • store between 20-25 degrees Celsius (68-77 degrees Fahrenheit).
  • Read all warnings and directions before use
  • Do not use if seal under bottle cap is broken or missing.
Inactive Ingredients

Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide

Questions Or Comments

Call 1-888-634-5522 Monday through Friday 9AM - 5PM EST.

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
  • 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 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

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.

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, 200mg (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 and seek medical help right away.

Stomach bleeding warning

: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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
Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless directed by a doctor ( see Warnings)
  • 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 other pain reliever/fever reduce

right before or after heart surgery

Package Label

Clear Choice

IBUPROFEN

MODERN PAIN MEDICINE

PAIN AND FEVER RELIEF

CONTAINS NO ASPIRIN

CAFFEINE FREE

Compare to Advil (R)

100 Tablets

200 mg each

This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Advil (R)

Manufactured for: A.N.I. Toledo, OH 43623 CODE 27541

Lot No.:

Exp. Date:







Other Information (Other information)
  • store between 20-25 degrees Celsius (68-77 degrees Fahrenheit).
  • Read all warnings and directions before use
  • Do not use if seal under bottle cap is broken or missing.
Inactive Ingredients (Inactive ingredients)

Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Iron Oxide Red, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch (Corn), Titanium Dioxide

Questions Or Comments (Questions or Comments)

Call 1-888-634-5522 Monday through Friday 9AM - 5PM EST.

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)
  • 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 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

If Pregnant Or Breast Feeding (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.

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, 200mg (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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