ADULT LOW STRENGTH ASPIRIN - aspirin tablet, coated
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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Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Use(s)

temporarily relieves minor aches and pains

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
shock
facial swelling
asthma (wheezing)

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 pain reliever or fever reducer

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 have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout
diabetes
arthritis

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
and allergic reaction occurs
new symptoms occur
ringing in the ears or loss of hearing occurs
pain gets worse or lasts more than 10 days
redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause prblems 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 and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours or as directed by a doctor.
children under 12 years: do not use unless directed by a doctor

Other information

store at controlled room temperature 15º-30ºF (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

cellulose, colloidal silicon dioxidem croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, shellac wax, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-877-932-7948

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

NDC 21130-414-12

Compare to St. Joseph® Adult

Low Strength active ingredient†

Adult Low Strength

Aspirin 81 mg (NSAID)

Aspirin Tablets, 81 mg

• Enteric Coated

•Pain Reliever

SEE NEW WARNINGS INFORMATION

ACTUAL SIZE

100 TABLETS

SAFEWAY™

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

50844 REV0110A41412

DISTRIBUTED BY SAFEWAY INC.

P.O. BOX 99, PLEASANTON, CA 94566-0009

Product Packaging

ADULT LOW STRENGTH ASPIRIN
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21130-414
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (ASPIRIN)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSES
POLYDEXTROSE
POLYETHYLENE GLYCOL
Polyvinyl Acetate Phthalate
DIMETHICONE
SODIUM ALGINATE
SODIUM BICARBONATE
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	44;414
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:21130-414-12	1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
1		100 TABLET, COATED (100 TABLET) in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (21130-414-12)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/14/2004

Labeler - Safeway (009137209)

Revised: 08/2011 Safeway