IBUPROFEN - ibuprofen tablet, coated
Rite Aid

----------

Active ingredient(s)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Use(s)

temporarily relives minor aches and pains due to:
headache
toothache
backache
menstrual cramps
the common cold
muscular aches
minor pain of arthritis
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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing precription 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
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

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 a doctor before use if

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 are taking a diuretic
you have problems or serious side effects from taking pain relievers or fever reducers
you have asthma

Ask a doctor or pharmacist before use if you are

under a doctor's care for any serious condition
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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
have bloody or black stools
vomit blood
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.

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 over: 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 24 hours, unless directed by a doctor
children under 12 years: ask a doctor

Other information

store between 20º-25ºC (68º-77ºF)
avoid excessive heat 40ºC (104ºF)
see end flap for expiriation date and lot number

Inactive ingredients

carnauba wax, cellulose, corn starch, FD&C yellow #6 aluminum lake, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

RITE

AID®

PHARMACY

Compare to the active ingredient in Motrin® IB†

Ibuprofen

tablets (NSAID), 200 mg

100 Coated Caplets**

**Capsule-Shaped Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV0910D39312

DISTRIBUTED BY:

Rite Aid

30 Hunter Lane

Camp Hill, PA 17011

Product Packaging

IBUPROFEN
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0393
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
FD&C YELLOW NO. 6
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	44;393
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:11822-0393-1	1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
1		100 TABLET, COATED (100 TABLET) in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (11822-0393-1)
2	NDC:11822-0393-5	1 BOTTLE, PLASTIC (1 CARTON) in 1 CARTON	contains a BOTTLE, PLASTIC
2		50 TABLET, COATED (50 TABLET) in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (11822-0393-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075139	04/08/2002

Labeler - Rite Aid (014578892)

Revised: 08/2011 Rite Aid