IBUPROFEN- ibuprofen capsule, coated
NASH-FINCH COMPANY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Our Family 44-292 Delisted

Active ingredient (in each brown 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
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
temporarily reduces fever

Warnings

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

hives
shock
facial swelling
skin reddening
asthma (wheezing)
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 3 or more alcoholic drinks every day while using this product
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspirin, iburpofen, naproxen, or others]
have had stomach ulcers or bleeding problems
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
fever gets worse or lasts more than 3 days
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 caplet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 caplet, 2 caplets may be used
- do not exceed 6 caplets 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)
see end flap for expiration date and lot number

Inactive ingredients

carnauba wax, corn stach, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, 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

SAFETY SEALED
Medicine for Body Aches and Pains

Compare to the Active Ingredient of Advil®†

Our Family®
Quality Care Since 1904

Ibuprofen
TABLETS USP, (NSAID), 200 mg
PAIN RELEIVER / FEVER REDUCER

100 CAPLETS**

**Caplets (Capsule-Shaped Tablets)

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Caplets.
50844 REV0411E29212

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

Our Family 44-292

IBUPROFEN
ibuprofen capsule, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70253-292
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BROWN	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	44;292
Contains

#	Item Code	Package Description
Packaging
1	NDC:70253-292-12	1 in 1 CARTON
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:70253-292-15	1 in 1 CARTON
2		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:70253-292-08	1 in 1 CARTON
3		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	05/24/1988	04/02/2018

Labeler - NASH-FINCH COMPANY (006962294)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(70253-292)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(70253-292)

Revised: 10/2015

Document Id: 2a5d9752-cad6-4ee8-9908-195d1bc7d82c

Set id: ec06a57e-e903-4e08-8b38-1b8128b28e69

Version: 3

Effective Time: 20151012

NASH-FINCH COMPANY