IBUPROFEN - ibuprofen capsule, liquid filled
Dolgencorp Inc

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Active ingredient (in each capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)
*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 an NSAID, which may cause severe 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 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 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

Ask a doctor or pharmacist before use if

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
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
stomach pain 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 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 6 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 20 mg
read all warnings and directions before use. Keep carton
store at 20° to 25°C (68° to 77°F)
avoid excessive heat above 40°C (104°F). Protect from light.
do not use Tamper- Evident seal under bottle cap imprinted with "Sealed for your protection" is broken or missing

Inactive ingredients

FD&C blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol.

Questions or comments?

call 1-888-309-9030

Principal Display Panel

Ibuprofen Capsules, 200 mg

Pain reliever/ fever reducer (NSAID)

20 softgels**

(**liquid filled capsules)

Compare to the active ingredient in Advil® †

†This product is not manufactured or distributed by Pfizer consumer healthcare, owner of the registered trademark Advil®

100 % Quality Guranteed (888)-309-9030

Distributed by DOLGENCORP, LLC

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

MADE IN U.S.A

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

SEE NEW WARNINGS INFORMATION

Product Label

Ibuprofen softgels 20 count

DG Ibuprofen 200 mg capsules

IBUPROFEN
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-199
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 BLUE NO. 1
GELATIN
POLYETHYLENE GLYCOLS
POTASSIUM HYDROXIDE
WATER
SORBITAN
SORBITOL

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	IB200
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:55910-199-20	1 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX	contains a BOTTLE, PLASTIC
1		20 CAPSULE, LIQUID FILLED (20 CAPSULE) in 1 BOTTLE, PLASTIC	This package is contained within the BOX (55910-199-20)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078682	07/07/2010

Labeler - Dolgencorp Inc (068331990)

Revised: 09/2012 Dolgencorp Inc