IBUPROFEN- ibuprofen tablet, film coated
NASH-FINCH COMPANY

----------

Our Family 44-392

Active ingredient (in each tablet)

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
- headache
- toothache
- menstrual cramps
- the common cold
- backache
- muscular aches
- minor pain of arthritis
temporarily reduces fever

Warnings

Allergy alert: Ibuprofen maay cause a severe allergic reaction, especially in people allergy to aspirin. Sympoms may include:

facial swelling
rash
hives
asthma (wheezing)
shock
skin reddening
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
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
any new symptoms appear
redness or swelling is present in the painful area
fever gets worse or lasts more than 3 days

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 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

store between 20º-25ºC (68º-77ºF)
avoid excessive heat 40ºC (104ºF)
used by expiration date on package

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

Medicine for Body Aches and Pains

Compare to the Active Ingredients of Motrin® IB Tablets†

Our Family®
Quality Care Since 1904

See New Warnings Information

Ibuprofen
Tablets USP (NSAID), 200 mg
Pain Reliever / Fever Reducer

50 TABLETS SAFETY SEALED

†This product is not manufactured or distributed by McNeil Consumer Health, Inc, owner of the registered trademark Motrin® IB Tablets.

DISTRIBUTED BY:
NASH FINCH COMPANY ©2004, 1996
NFC BRANDS
7600 FRANCE AVE S, MPLS, MN 55435
www.ourfamilyfoods.com NF16388
50844 REV0411D39215

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

Our Family 44-392

IBUPROFEN
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70253-392
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;392
Contains

#	Item Code	Package Description
Packaging
1	NDC:70253-392-15	1 in 1 CARTON
1		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075139	03/30/2002	04/02/2018

Labeler - NASH-FINCH COMPANY (006962294)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(70253-392, 70253-392)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(70253-392, 70253-392)

Revised: 10/2015

Document Id: e964bc7e-c786-454a-9523-74b3c770f4dd

Set id: f7c1d2bc-7199-4f29-a9d8-75a7cdea320a

Version: 2

Effective Time: 20151012

NASH-FINCH COMPANY