IBUPROFEN- ibuprofen tablet, film coated
Better Living Brands, LLC

----------

Safeway 44-292-Delisted

Active ingredient (in each brown caplet)

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
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:

have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
are age 60 or older
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
take more or for a longer time than directed
have 3 or more alcoholic drinks every day while using this product

Do not use

right before or after heart surgery
if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

you have asthma
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you are taking a diuretic
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you have problems or serious side effects from taking pain relievers or fever reducers

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 starch, 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

NDC 21130-292-08

SAFEWAY®
care

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

Quality Guaranteed

Actual Size

24 CAPLETS

Compare to
Advil® Caplets active ingredient†

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Advil® Caplets.
50844 ORG041129208

DISTRIBUTED BY SAFEWAY INC.
P.O. BOX 99, PLEASANTON, CA 94566-0009
QUALITY & SATISFACTION GUARANTEED OR YOUR MONEY BACK
1-888-SAFEWAY / www.safeway.com

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

Safeway 44-292

IBUPROFEN
ibuprofen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21130-292
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)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE (UNII: J2B2A4N98G)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	BROWN	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	44;292
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:21130-292-08	1 in 1 CARTON	05/24/1988	09/12/2019
1		24 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	ANDA075010	05/24/1988	09/12/2019

Labeler - Better Living Brands, LLC (009137209)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(21130-292)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(21130-292)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(21130-292)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(21130-292)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(21130-292)

Revised: 11/2017

Document Id: 305196c7-1d56-4a02-8770-54015b2d1b76

Set id: ac55cec2-9c40-4963-add1-9f4decb1d816

Version: 6

Effective Time: 20171115

Better Living Brands, LLC