ASPIRIN- aspirin tablet 
Safeway

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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Safeway 44-157

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer


Uses

provides temporary relief of

  • headache
  • pain and fever of colds
  • muscle pain
  • toothache
  • menstrual pain
  • minor pain of arthritis


Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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 more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription and nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product


Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer.


Ask a doctor before use if

  • you have liver cirrhosis
  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have heart or kidney disease
  • you are taking a diuretic
  • you have high blood pressure
  • you have asthma


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
  • taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • an allergic reaction occurs.  Seek medical help right away.
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms occur
  • fever gets worse or lasts more than 3 days
  • ringing in the ears or loss of hearing occurs


If pregnant or breast-feeding,

ask a health professional before use.  It is especially important not tuse aspirin 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

  • drink a full glass of water with each dose
  • adults: 1 to 2 tablets with water. Dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours.
  • children under 12: consult a doctor


Other information

  • store at room temperature


Inactive ingredients

hypromellose, starch, titanium dioxide


Questions or comments?

1-800-426-9391

Principal display panel

NDC 21130-157-12

Compare to Bayer® active ingredient†

Aspirin
325 mg
• Pain Reliever/
  Fever Reducer (NSAID)

100 coated tablets

†This product is not manufactured or distributed by Bayer® HealthCare LLC, distributor of Bayer® Aspirin.
50844    REV1011B15712

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

Safeway 44-157

Safeway 44-157

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:21130-157
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code ASPIRIN;44157
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-157-12100 in 1 BOTTLE
2NDC:21130-157-14500 in 1 BOTTLE
3NDC:21130-157-17300 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34302/10/2006
Labeler - Safeway (009137209)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(21130-157)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(21130-157)

Revised: 6/2013
Document Id: 6a82cf66-a806-4331-b6a6-d13a85ec6fec
Set id: 4530a512-4234-4926-96ba-de61f14b1996
Version: 1
Effective Time: 20130610
 
Safeway