DrugCite

ASPIRIN - aspirin tablet, chewable 
AAA Pharmaceutical, Inc.

Aspirin Tablets

Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID1)


1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for this product

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

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 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 reaction to any other pain reliever/fever reducer

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:

  • diabetes
  • gout
  • arthritis

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 for more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs

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, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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; do not exceed 48 tablets in 24 hours
  • children under 12 years: consult a doctor

Other information

  • store between 20°-25°C (68°-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

butylated hydroxytoluene, colloidal silicon dioxide, dextrates, FD&C yellow #6, flavor, mannitol, microcrystalline cellulose, modified corn starch, pregelatinized starch, saccharin sodium, starch, stearic acid, sucrose

Distributed by:
AAA Pharmaceutical, Inc.
681 Main Street
Lumberton, NJ 08048

PRINCIPAL DISPLAY PANEL - 36 Tablet Bottle Carton

RESTORE u

NDC 57344-105-01

COMPARE TO THE ACTIVE
INGREDIENT IN BAYER®
CHEWABLE ASPIRIN

LOW DOSE

Chewable Aspirin
Pain Reliever
(NSAID)

Orange
Flavored

81mg

36 TABLETS - 81 mg each

Principal Display Panel - 36 Tablet Bottle Carton

ASPIRIN 
aspirin  tablet, chewable
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 57344-105
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
BUTYLATED HYDROXYTOLUENE  
SILICON DIOXIDE  
DEXTRATES  
FD&C YELLOW NO. 6  
MANNITOL  
CELLULOSE, MICROCRYSTALLINE  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)  
STARCH, CORN  
SACCHARIN SODIUM  
STEARIC ACID  
SUCROSE  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 9mm
Flavor ORANGE Imprint Code TCL;334
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 57344-105-01 1  In 1 CARTON contains a BOTTLE, PLASTIC
1 36  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-105-01)
2 57344-105-03 3  In 1 CARTON contains a BOTTLE, PLASTIC
2 36  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-105-03)
3 57344-105-05 2  In 1 CARTON contains a BOTTLE, PLASTIC
3 36  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-105-05)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 12/15/2012

Labeler - AAA Pharmaceutical, Inc. (181192162)
Revised: 12/2012AAA Pharmaceutical, Inc.