FDA Label for Aspirin

Active Ingredient

Active ingredient (in each tablet)

Aspirin325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Purpose

Pain reliever/fever reducer

Indications & Usage

Uses

Temporarily relieves

• headache
• muscle pain
• minor pain of arthritis
• pain and fever of colds
• toothache
• menstrual pain

Warnings

Warnings

Other

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.

Adults and children: (12 years and over) Take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours.


Children under 12 years: Consult a doctor

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

Do not use if you are allergic to aspirin or to any other pain reliever/fever reducer

Ask 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 are taking a diuretic
• you have asthma

Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug for

• gout
• diabetes
• arthritis

Stop Use

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
• 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 lasts more than 3 days
  • if ringing in the ears or loss of hearing occurs
  • redness or swelling is present
  • new symptoms appear
  
  

Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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.

Dosage & Administration

Directions

• drink a full glass of water with each dose

Other Safety Information

Other information

• store at room temperature
• avoid excessive heat and humidity
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive Ingredient

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol

Questions

Questions or comments? (888) 602-0288

Principal Display Panel – 250 Tablet Box Label

2501

5 GRAIN

ASPIRIN

Pull to Open

For Temporary Relief of Minor Aches and Pains

The Provision

First Aid

Line™

BY WILDMAN

250 Tablets

2 Per Packet

Figure - asp0n 0000 01