HENRY SCHEIN ASPIRIN- aspirin tablet, film coated 
Henry Schein, 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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Drug Facts

Active ingredient (in each tablet)

Aspirin (NSAID*) 325 mg

Purpose

Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug

Uses

Temporarily relieves minor aches and pains associated with

  • headache
  • minor arthritis
  • common cold
  • menstrual cramps
  • muscular aches
  • backache
  • toothache

Temporarily reduces 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.

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 have ever had an allergic reaction to any other pain reliever/ fever reducer
  • right before or after heart surgery
  • if you are taking prescription drugs for gout, diabetes or arthritis

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

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious condition
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

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
  • you have difficulty swallowing
  • if ringing in the ears or loss of hearing occurs
  • redness or swelling is present in the painful
    area
  • any new symptoms appear

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.

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless
    directed by a doctor (see Warnings)
  • 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 as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

Other information

  • read all product information before using
  • store at room temperature 59º-86ºF (15º-30ºC)
  • avoid excessive heat and humidity
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

hypromellose, polyethylene glycol, propylene glycol, starch, corn

Questions or comments?

1-800-472-4346

116R HS Aspirin Label

NDC #0404-0710-13

Henry Schein®

Aspirin

For temporary relief of minor aches and pains associated with headache, muscular aches, minor arthritis pain, backache, common cold, toothache, menstrual cramps, and for the reduction of fever.

Henry Schein

Seal Of Excellence®

Aspirin 325 mg

(NSAID)

250 Packets/2 Tablets

Reorder

900-4688

See new warnings information

Figure
HENRY SCHEIN ASPIRIN 
aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0710
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
POLYETHYLENE GLYCOL 
PROPYLENE GLYCOL 
STARCH, CORN 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code 44;157;aspirin
Contains    
Packaging
#Item CodePackage Description
1NDC:0404-0710-13250 in 1 BOX, UNIT-DOSE
1NDC:0404-0710-992 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/30/200809/26/2013
Labeler - Henry Schein, Inc. (012430880)

Revised: 07/2011
 
Henry Schein, Inc.