Clear Choice Ibuprofen
FDA Label NDC 53185-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Athlete's Needs Inc for the product Clear Choice Ibuprofen (NDC 53185-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Tablet)

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

Purpose

Pain reliever/fever reducer

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

Do Not Use

if you have ever had an allergic reaction to other pain reliever/fever reduce

right before or after heart surgery

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

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

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

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).

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

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.

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:

Main Label (Label1)

Main Label (Label1)


Drug Facts Label (Label2)

Drug Facts Label (Label2)


Drug Facts Label (Label3)

Drug Facts Label (Label3)


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