IBUPROFEN - ibuprofen tablet
Apotheca Inc.

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Ibuprofen Tablets, USP (NSAID)Pain Reliever/ Fever ReducerDRUG FACTS

ACTIVE INGREDIENT

(in each Tablet)

Ibuprofen 200 mg (NSAID)**

**nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USES

temporarily relieves minor aches and pains due to:
headache
muscular aches
minor pain or 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.

Alcohol Warning: If you consume 3 or more alcohol drinks per day, ask your Doctor whether you should take Ibuprofen or other pain relievers/fever reducers.

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is 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 NSAID (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 any other pain reliever/fever reducer
right before or after heart surgery

ASK DOCTOR

Ask a doctor before use if you have

problems or serious side effects from taking pain relievers or fever reducers
stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
ulcers
bleeding problems
high blood pressure
heart or kidney disease
taken a diuretic
reached age 60 or older

Ask a doctor before use if you are

taking aspirin for heart attack or stroke because ibuprofen may decrease this benefit of aspirin
taking any other drug containing an NSAID (prescription or nonprescription)
taking a blood thinning (anticoagulant) or steroid drug
under a doctor's care for any serious condition
taking any other drug
consuming 3 or more alcohol drinks per day

WHEN USING THIS PRODUCT

take with food or milk if stomach upset occurs
long term continuous use ay increase the risk of heart attack or stroke

STOP USE AND ASK A DOCTOR IF

you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
stomach pain or upset gets worse or lasts
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 1-800-362-0101 (Arizona only) immediately.

DIRECTIONS

do not take longer than 10 days, unless directed by a doctor (see Warnings)


Adults and children 12 years and older	take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in a 24-hour period, unless directed by a physician take with food or milk, if occasional and mild heartburn, upset stomach, or stomach pain occurs with use consult a physician if these symptoms are more thsn mild or if they persist
Children under 12 years	not for use

OTHER INFORMATION

Other information

store at 15 – 30°C (59-86°F).

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, Corn Starch, Titanium Dioxide.

QUESTIONS OR COMMENTS

Call 1-800-262-5244

Monday though Friday 9AM – 2PM MST

Distributed by:

RejuviLife, Phoenix, AZ

RejuviLife is a trademark of Apotheca Inc.

PACKAGE LABEL,PRINCIPAL DISPLAY PANEL,ADDITIONAL LABELS UPON REQUEST

NDC 12634-860-01

IBUPROFEN

MAXIMUM STRENGTH
WITHOUT A PRESCRIPTION

Pain Reliever
Fever Reducer

RejuviLife®

100 CAPLETS

200 MG

image of label

IBUPROFEN
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	12634-860 (53746-142)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (IBUPROFEN)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE
CARNAUBA WAX
SILICON DIOXIDE
HYPROMELLOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE

Product Characteristics
Color	brown (BROWN)	Score	no score
Shape	OVAL (CAPSULE-SHAPE)	Size	13mm
Flavor		Imprint Code	IP;142
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	12634-860-24	24 TABLET In 1 BOTTLE, PLASTIC	None
2	12634-860-01	100 TABLET In 1 BOTTLE, PLASTIC	None
3	12634-860-10	1000 TABLET In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071333	09/16/2009

Labeler - Apotheca Inc. (051457844)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Inc.		051457844	relabel, repack

Revised: 02/2010Apotheca Inc.