CLEAR CHOICE IBUPROFEN - ibuprofen tablet 
Athlete's Needs Inc

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Clear Choice Ibuprofen

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

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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:

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

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

Other information

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 Type HUMAN OTC DRUG Item Code (Source) NDC:53185-003
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color brown (brown) Score no score
Shape ROUND (round) Size 9mm
Flavor Imprint Code IBU200
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53185-003-00 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079129 10/09/2012
Labeler - Athlete's Needs Inc (619703945)
Registrant - Athlete's Needs Inc (619703945)
Establishment
Name Address ID/FEI Business Operations
Athlete's Needs Inc 619703945 manufacture(53185-003)

Revised: 10/2012
Document Id: 31ab6ec9-33a6-465c-a512-d5c45b353705
Set id: 20bde9bd-7b13-4be4-9cba-ebc10c834a7a
Version: 1
Effective Time: 20121009
 
Athlete's Needs Inc