ASPIRIN - aspirin tablet, chewable
Western Family Foods 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.

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Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of 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
for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask a doctor before use if

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
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
new symptoms appear
ringing in the ears or a 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 not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years: ask a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

dextrose excipient, FD&C yellow no. 6 lake, flavors, saccharin sodium, starch

Principal Display Panel

See New Warnings Information

Low Dose

Aspirin Regimen

Aspirin

81 mg

Orange Flavor

Chewable

Pain Reliever (NSAID)

Gluten Free

Compare to Bayer® Chewable Aspirin active ingredient

Aspirin Carton Image 1

Aspirin Carton Image 2

ASPIRIN
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-467
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
SACCHARIN SODIUM
DEXTROSE
FD&C YELLOW NO. 6

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	8mm
Flavor	ORANGE	Imprint Code	L467
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:55312-467-68	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		36 TABLET, CHEWABLE ( TABLET) in 1 BOTTLE	This package is contained within the CARTON (55312-467-68)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/30/1993

Labeler - Western Family Foods Inc (192166072)

Revised: 04/2010 Western Family Foods Inc