Label: HENRY SCHEIN ASPIRIN- aspirin tablet, film coated
- NDC Code(s): 0404-0164-13
- Packager: Henry Schein, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 14, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- INACTIVE INGREDIENT
- QUESTIONS
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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
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INGREDIENTS AND APPEARANCE
HENRY SCHEIN ASPIRIN
aspirin tablet, film coatedProduct 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 not final part343 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)