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Name:Aspirin
Manufacturer:Cardinal Health
Category:Over-the-counter (OTC) Marketed Drugs


Leader 44-218-SJ

ASPIRIN - aspirin tablet, chewable 
CARDINAL HEALTH

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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Leader 44-218-SJ

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • temporarily relieves minor aches and pains

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

  • shock

  • asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • have had stomach ulcers or bleeding problems

  • are age 60 or older
  • 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 have ever had an allergic to aspirin or any other pain reliever or fever reducer

  • 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 have asthma
  • user takes a diuretic

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

    • have bloody or black stools

    • vomit blood

    • have stomach pain that does not get better

  • an allergic reaction occurs. Seek medical help right away.

  • new symptoms occur

  • ringing in the ears or loss of hearing occurs

  • pain gets worse or lasts more than 10 days

  • redness or swelling is present

These could be signs of a serious condition.

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, 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 over: take 4 to 8 tablets every 4 hours while symptoms persist.  Do not exceed 48 tabletsin 24 hours or as directed by a doctor.
  • children under 12: do not use unless directed by  a doctor

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

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

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

NDC 37205-369-68

LEADER®

SEE NEW WARNINGS INFORMATION

Compare to St. Joseph® active ingredient†

Aspirin

Pain reliever (NSAID)

81 mg Chewable

Adult Low Strength Aspirin Regimen

Orange Flavored

36 TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844    REV0310D21807

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

CIN 3510955        www.myleader.com        1-800-200-6313

Product Packaging

Product Packaging


ASPIRIN 
aspirin tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-218
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
DEXTRATES  
ETHYLCELLULOSES  
FD&C YELLOW NO. 6  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 8mm
Flavor ORANGE Imprint Code 44;218
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37205-218-23 1 BOTTLE (1 BOTTLE) in 1 CARTON contains a BOTTLE
1 72 TABLET, CHEWABLE (72 TABLET) in 1 BOTTLE This package is contained within the CARTON (37205-218-23)
2 NDC:37205-218-07 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
2 36 TABLET, CHEWABLE (36 TABLET) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (37205-218-07)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 09/12/1990

Labeler - CARDINAL HEALTH (097537435)

Revised: 06/2011 CARDINAL HEALTH



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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