DrugCite

ASPIRIN - aspirin tablet, coated 
AAA Pharmaceutical, Inc.

Aspirin Tablets

Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID1)


1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves:
    • headache
    • muscle pain
    • toothache
    • menstrual pain
    • pain of colds
    • minor pain of arthritis
  • 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 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
  • fever gets worse or lasts for more than 3 days
  • 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 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

Other information

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

Inactive ingredients

croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, starch, titanium dioxide

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

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

RESTORE u

NDC 57344-018-11

COMPARE TO THE
ACTIVE INGREDIENT IN
BAYER® ASPIRIN

REGULAR
STRENGTH

Coated for
Easy Swallowing

Aspirin
Pain Reliever / Fever Reducer
(NSAID)

100 COATED TABLETS - 325 mg each

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

ASPIRIN 
aspirin  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 57344-018
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
HYPROMELLOSES  
CELLULOSE, MICROCRYSTALLINE  
MINERAL OIL  
POLYETHYLENE GLYCOLS  
STARCH, CORN  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code TCL;011
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 57344-018-11 1  In 1 CARTON contains a BOTTLE, PLASTIC
1 100  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-018-11)
2 57344-018-14 1  In 1 CARTON contains a BOTTLE, PLASTIC
2 300  In 1 BOTTLE, PLASTIC This package is contained within the CARTON (57344-018-14)
3 57344-018-15 500  In 1 BOTTLE, PLASTIC None
4 57344-018-17 300  In 1 BOTTLE, PLASTIC None
5 57344-018-08 100  In 1 BOTTLE, PLASTIC None
6 57344-018-09 1000  In 1 BOTTLE, PLASTIC None

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.