Aspirin

GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

Healthcare 44-218

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• Aspirin Uses
• Warnings
  • Do not use
  • Ask a doctor before use if
  • Ask a doctor or pharmacist before use if
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • Keep out of reach of children
• Directions
• Aspirin Other information
• Inactive ingredients
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Aspirin 81 mg  [1 1/4 gr] (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Aspirin Uses

• temporarily relieves minor aches and pains due to:

  • headache

  • toothache

  • the common cold

  • sore throat

• 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.

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 the user:

• has had stomach ulcers or bleeding problems

• takes a blood thinning (anticoagulant) or steroid drug

• is age 60 or older

• takes more or for a longer time than directed

• takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

• has 3 or more alcoholic drinks every day while using this product

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• if you are allergic to aspirin or any other pain reliever/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 user

• user has a history of stomach problems, such as heartburn

• user has asthma

• user has high blood pressure, heart disease, liver cirrhosis or kidney disease

• user takes a diuretic

• user has lost a lot of fluid due to vomiting or diarrhea

• user has not been drinking fluids

Ask a doctor or pharmacist before use if

taking a prescription drug for

• gout
• diabetes
• arthritis

Stop use and ask a doctor if

• user experiences any of the following signs of stomach bleeding:

  • vomits blood

  • has bloody or black stools

  • feels faint

  • has 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

• pain gets worse or lasts more than 5 days in children under 12

• fever gets worse or lasts more than 3 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

• to be administered only under adult supervision
• if possible, use weight to determine dose.  Otherwise use age.

Aspirin 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.

HEALTHCARE™

NDC 64092-000-36

81 mg LOW STRENGTH

Children's Low Dose Aspirin

Pain Reliever/Fever Reducer (NSAID)

SEE NEW WARNINGS INFORMATION

Orange Flavor

36 CHEWABLE TABLETS

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

50844    REV0310A21836

Distributed by: Great Lakes Wholesale & Marketing, L.L.C.

3729 Patterson Ave., S.E., Grand Rapids, MI 49512

www.glwholesale.com