Active ingredient (in each tablet)

Ibuprofen USP 200 mg (NSAID)1

1: nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

headache
the common cold
toothache
muscular aches

backache
minor pain of arthritis
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 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 an 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 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
asthma
taken a diuretic
reached age 60 or older

Ask a doctor or pharmacist before use if you are

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 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 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 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 of age and over: 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

TAMPER-EVIDENT: Each tablet is individually sealed. Do not use if blister is torn or broken.
read all warnings and directions before use
store at 20° - 25°C (68° - 77°F)
avoid excessive heat above 40°C (104°F)

Inactive ingredients

acacia, calcium carbonate, carnauba wax, confectioner's sugar, crospovidone, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, kaolin, pharmaceutical ink, polyethylene glycol, powdered cellulose, pregelatinized starch, silicon dioxide, sodium benzoate, starch, sucrose, talc, titanium dioxide, white wax

Questions?

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

This unit dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.

Manufactured for:
GOLDLINE LABORATORIES, INC.
Sellersville, PA 18960
by: Ohm Laboratories, Inc.
North Brunswick, NJ 08902

0309REV 420

PRINCIPAL DISPLAY PANEL - 10 × 10 Tablets

NDC 0182-8688-89

TAMPER-EVIDENT

IBUPROFEN
TABLETS USP

200 mg

PAIN RELIEVER/
FEVER REDUCER (NSAID*)
*nonsteroidal anti-inflammatory drug

100 (10×10) unit-dose tablets

Goldine

PRINCIPAL DISPLAY PANEL - 10 × 10 Tablets

IBUPROFEN
ibuprofen tablet, sugar coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0182-8688
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
acacia
calcium carbonate
carnauba wax
sucrose
crospovidone
gelatin
guar gum
hydroxypropyl cellulose
kaolin
POLYETHYLENE GLYCOLS
POWDERED CELLULOSE
starch, corn
silicon dioxide
sodium benzoate
talc
titanium dioxide

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND (Biconvex)	Size	10mm
Flavor		Imprint Code	420
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0182-8688-89	10 BLISTER PACK in 1 CARTON	contains a BLISTER PACK
1		10 TABLET, SUGAR COATED in 1 BLISTER PACK	This package is contained within the CARTON (0182-8688-89)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA071163	07/15/1986	05/31/2011

Labeler - Goldline Laboratories, Inc. (032349292)

Revised: 09/2012 Goldline Laboratories, Inc.