IBUPROFEN - ibuprofen tablet, coated
Rugby Laboratories, Inc.

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Active Ingredient (in each capsule)

Solubilized Ibuprofen equal to 200mg Ibuprofen (NSAID)*
(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Releiver/ Fever Reducer

Uses

Temporarily relieves minor aches and pains due to:

Headache, muscle aches, minor pain of arthritis, toothache, backache, the common cold, menstrual cramps

Temporarily reduces fever.

Warnings

Allergy alert: Ibuprofen may cause a sever 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 an seek medical help right away.

Stomach bleeding warning: This prdut contains and NSAID which may cause sever stomach bleeding. The chance is higher if you:

are age 60 or oder
have had stomach ulders or bleeding problems
take blood thinning (anticoagulant) or steroid drug
take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks everyday while using this prdouct
take more or for a longer time than directed.

Do not use

if you ever had an allergic reaction to any other pain reliever/fever reducer
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 are taking a diuretic.

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 ifyou use more than directed or for longer than directed.

Stop use and ask a doctor if

You experience any of the followig signs of stomach bleeding:

feel faint
vomit blood
have bloody or black stoolos
have stomach pain that does not bet better

Pain gets worse or last more than 10 days

Fever gets worse or last more than 3 days

Stomach pain or upset gets worse or lasts

Redness or swelling is presentin 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 druing the last 3 months of pegnancy unless defintely 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

Adults and children 12 years and over:

take 1 capsule every 4 to 5 hours while symptoms persist

if pain or fever does not respond to 1 capsule, 2 capsules may be used.

do not exceed 6 capsules in 24 hours, unless directed by a doctor

children under 12 years: ask a doctor

Other information

each capsule contains

potassium 20mg

read all warnings and directions before use

store at 20-25C (68-77F)

avoid excessive heat above 40c (104F). Protect from light.

do not use if Tamper-Evident seal under bottle cap imprented with "Sealed for Your Protection" is broken or missing.

Inactive Ingredients

colloidal silicon dioxide, corn starch, dextrose monohydrate, hypromellose, iron oxide red, lactose monohydrate, lecithin, maltodextrin, povidone (K-30), pregelatinized starch, sodium carboxymethylcellulose, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

Questions or comments?

Call 1-800-645-2158, 9am - 5pm ET, Monday - Friday

Duluth, Georgia 30097
www.rugbylaboratories.com

Package Labeling

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN NDC: 0536-3587-10

Non-Prescription Strength

Ibuprofen

Tablets USP, 200mg

Pain Reliever/Fever Reducer (NSAID)

1000 BROWN COATED TABLETS

Ibuprofen

IBUPROFEN
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-3587
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
COLLOIDAL SILICON DIOXIDE
DEXTROSE MONOHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MALTODEXTRIN
POVIDONE K30
STARCH, PREGELATINIZED CORN
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	G2
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0536-3587-06	50 TABLET, COATED in 1 BOTTLE	None
2	NDC:0536-3587-02	250 TABLET, COATED in 1 BOTTLE	None
3	NDC:0536-3587-10	1000 TABLET, COATED in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079174	03/26/2012

Labeler - Rugby Laboratories, Inc. (109178264)

Establishment
Name	Address	ID/FEI	Operations
P and L Development of New York Corporation		800014821	relabel, repack

Establishment
Name	Address	ID/FEI	Operations
Banner Pharmacaps Inc		002193829	manufacture

Revised: 04/2012 Rugby Laboratories, Inc.