ASPIRIN CHEWABLE- aspirin 81 mg tablet
Medical Purchasing Solutions, LLC

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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Drug Facts

Active ingredient

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

Purpose

Pain reliever/fever reducer

Uses

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

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 aspirin or 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
You may report side effects to 1-888-952-0050

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 PoisonControlCenter 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 not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

Inactive Ingredients

dextrates, FD&C yellow #6, flavor, saccharin sodium, starch

HOW SUPPLIED

NDC: 71872-7087-4

4 TABLETs in a BLISTER PACK

pdp

ASPIRIN CHEWABLE
aspirin 81 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71872-7087(NDC:63739-434)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71872-7087-4	4 in 1 BAG	03/05/2018
1		30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	12/18/2014	05/31/2021

Labeler - Medical Purchasing Solutions, LLC (601458529)

Name	Address	ID/FEI	Business Operations
Establishment
Medical Purchasing Solutions. LLC		601458529	repack(71872-7087)

Revised: 6/2023

Document Id: fe446d7c-9c4a-a853-e053-6394a90a1d46

Set id: 677a9e9d-3071-35f2-e053-2a91aa0ab779

Version: 3

Effective Time: 20230616

Medical Purchasing Solutions, LLC