IBUPROFEN- ibuprofen capsule, coated 
Safeway

----------

Safeway 44-393

Active ingredient (in each orange caplet)

 Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

 Pain reliever/fever reducer

Uses

Warnings

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

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:

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 asthma
  • 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 

Ask a doctor or pharmacist before use if

  • 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 of 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 complication during delivery.

Keep out of reach of children

 In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

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

NDC 21130-291-08
Compare to Motrin® IB active ingredient†

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

SEE NEW WARNINGS INFORMATION

100 CAPLETS**     **Capsule-shaped tablets

SAFEWAY

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Motrin® IB.

50844        REV0411C39312

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

Safeway 44-393

Safeway 44-393

IBUPROFEN 
ibuprofen capsule, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-393
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
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 CAPSULE Size 14mm
Flavor Imprint Code 44;393
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21130-393-12 1 in 1 CARTON
1 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075139 04/08/2002
Labeler - Safeway (009137209)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(21130-393)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(21130-393)

Revised: 10/2012
Document Id: b595ffc1-3833-4496-8211-60240d52ca8f
Set id: 45520969-7a2d-4469-ba25-7db160d50ccf
Version: 1
Effective Time: 20121005
 
Safeway