Your browser does not support JavaScript! CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]
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RxNorm Names

CLEAR CHOICE IBUPROFEN (ibuprofen) tablet
[Athlete's Needs Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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

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

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

drug facts label

drug facts label

CLEAR CHOICE IBUPROFEN 
ibuprofen tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53185-003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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 
Product Characteristics
Colorbrown (brown) Scoreno score
ShapeROUND (round) Size9mm
FlavorImprint Code IBU200
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53185-003-00100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07912910/09/2012
Labeler - Athlete's Needs Inc (619703945)
Registrant - Athlete's Needs Inc (619703945)
Establishment
NameAddressID/FEIBusiness Operations
Athlete's Needs Inc619703945manufacture(53185-003)

Revised: 10/2012
 
Athlete's Needs Inc

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