CLEAR CHOICE IBUPROFEN- ibuprofen tablet

Clear Choice Ibuprofen by

Drug Labeling and Warnings

Clear Choice Ibuprofen by is a Otc medication manufactured, distributed, or labeled by Athlete's Needs Inc, Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

CLEAR CHOICE IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53185-003
Route of Administration	ORAL

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; Type 0: Not a Combination Product	06/03/2013

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
Allegiant Health		079501930	manufacture(53185-003)