ASPIRIN - aspirin tablet, film coated
Meijer Distribution Inc

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.

----------

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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
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 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 other pain reliever/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 are taking a diuretic
you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.
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
pain gets worse or lasts for more than 10 days
redness or swelling is present
any new symptoms appear
ringing in the ears or loss of hearing occurs

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 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. (1-800-222-1222)

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 20º-25ºC (68º-77ºF)

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, edible ink, FD&C red no. 3, FD&C red no. 40, FD&C yellow no. 6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, pregelatinized starch, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions?

1-800-719-9260

Principal Display Panel

See New Warnings Information

Aspirin

Adult Low Strength - 81 mg

Enteric Safety Coated

Pain Reliever (NSAID)

Compare to St.Joseph® active ingredient

Aspirin Regimen

Adult Low Strength, 81 mg Aspirin Carton

ASPIRIN
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-277
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
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C RED NO. 3
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
STEARIC ACID
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE

Product Characteristics
Color	ORANGE (peach)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	L277
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:41250-277-48	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		180 TABLET, FILM COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (41250-277-48)
2	NDC:41250-277-15	2 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
2		180 TABLET, FILM COATED ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (41250-277-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/11/1992

Labeler - Meijer Distribution Inc (006959555)

Revised: 09/2009 Meijer Distribution Inc