HENRY SCHEIN ASPIRIN- aspirin tablet, film coated

Henry Schein Aspirin by

Drug Labeling and Warnings

Henry Schein Aspirin by is a Otc medication manufactured, distributed, or labeled by Henry Schein, Inc., Unifirst First Aid Corporation, Prestige Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Aspirin (NSAID*) 325 mg
*nonsteroidal anti-inflammatory drug

PURPOSE

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

Temporarily relieves minor aches and pains due to:

■ headache

■ minor pain of arthritis

■ colds

■ menstrual pain

■ muscle pain

■ toothache

Temporarily reduces fever.

WARNINGS

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

If an allergic reaction occurs, stop use and seek medical help right away.

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 alcohol 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 to any other pain reliever/fever reducer

■ if you ever had an allergic reaction to this product or any of its ingredients

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

■ 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

■ fever gets worse or lasts more than 3 days

■ if ringing in the ears or loss of hearing occurs

■ redness or swelling is present in the painful area

■ any new symptoms occur

PREGNANCY OR BREAST FEEDING

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

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 older)

Take 1 or 2 tablets with water every 4 hours or 3 tablets every 6 hours, not
to exceed 12 tablets in 24 hours

Children under 12 years: Do not give to children under 12 years of age unless directed by a doctor.

Other information

■ store at 77ºF (25ºC); excursions permitted between 59º-86ºF (15° - 30°C)

■ avoid excessive heat and humidity

■ tamper evident sealed packets

■ do not use any open or torn packets

■ use by expiration date on packageed

INACTIVE INGREDIENT

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol

QUESTIONS

Questions or comments? 1-800-472-4346

Henry Schein Aspirin Label

Henry Schein®

Aspirin

For the temporary relief of minor aches and pains

associated with headache, muscular aches, minor arthritis pain, backache,

common cold, toothache, menstrual cramps and the reduction of fever.

Henry Schein Seal of Excellence®

Pull to Open

This Package is for Households Without Young Children.

Aspirn 325 mg (NSAID)

250 Packets/ 2 Tablets Reorder

570-2005

INGREDIENTS AND APPEARANCE

HENRY SCHEIN ASPIRIN 
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-0164
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	ASPIRIN;44;157
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-0164-13	250 in 1 BOX	07/20/2020
1		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/20/2020

Labeler - Henry Schein, Inc. (012430880)

Registrant - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		080667761	pack(0404-0164)