ASPIRIN CHEWABLE- aspirin 81 mg tablet

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by McKesson Corporation dba SKY Packaging, Legacy Pharmaceutical Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

temporary relief of minor aches and pains or as recommended by your doctor

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 are allergic to aspirinor any other pain reliever/fever reducer this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

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

• gout
• diabetes
• 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 more than 10 days
• redness or swelling is present
• new symptoms occur
• 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 to use aspirin during the last 3 months of pregnancy unless specifically 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 accidental overdose, get medical help or contact a Poison Control Center(1-800-222-1222) immediately.

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: consult a doctor

Inactive Ingredients

corn starch, dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium 

HOW SUPPLIED

Product: 63739-434

NDC: 63739-434-01 30 TABLET in a BLISTER PACK / 25 in a BOX, UNIT-DOSE

Drug Facts

INGREDIENTS AND APPEARANCE

ASPIRIN  CHEWABLE
aspirin 81 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63739-434(NDC:69168-288)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
DEXTRATES (UNII: G263MI44RU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	7mm
Flavor	ORANGE	Imprint Code	AZ013
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63739-434-01	25 in 1 BOX, UNIT-DOSE	08/02/2016
1		30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	12/18/2014

Labeler - McKesson Corporation dba SKY Packaging (140529962)

Establishment
Name	Address	ID/FEI	Business Operations
McKesson Corporation dba RX Pak		025183281	REPACK(63739-434)