IBUPROFEN - ibuprofen tablet, sugar coated 
Goldline Laboratories, Inc.

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Ibuprofen Tablets USP

Drug Facts

Active ingredient (in each tablet)

Ibuprofen USP 200 mg (NSAID)1

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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

IBUPROFEN  ibuprofen   tablet, sugar coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 glycol   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 # NDC Package Description Multilevel Packaging 1 0182-8688-89 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET 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	03/01/2009

Labeler - Goldline Laboratories, Inc. (032349292)

Revised: 07/2009Goldline Laboratories, Inc.