ASPIRIN- aspirin tablet, delayed release 
AAA Pharmaceutical, Inc.

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.

----------

Aspirin Tablets

Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID1)


1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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:

  • gout
  • diabetes
  • 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

Other information

Inactive ingredients

acetylated monoglycerides, anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40, FD&C yellow #6, hypromellose, hypromellose phthalate, iron oxide yellow, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polyethylene glycol, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

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

PRINCIPAL DISPLAY PANEL - 180 Tablet Bottle Carton

RESTORE u

NDC 57344-146-01

COMPARE TO THE ACTIVE
INGREDIENT IN ST JOSEPH®
SAFETY COATED ASPIRIN

ADULT
LOW DOSE

Safety
Coated

Aspirin
Pain Reliever
(NSAID)

81mg

180 ENTERIC COATED TABLETS - 81 mg each

PRINCIPAL DISPLAY PANEL - 180 Tablet Bottle Carton
ASPIRIN 
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:57344-146
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
DIACETYLATED MONOGLYCERIDES 
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) 
FERRIC OXIDE YELLOW 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
DIMETHICONE 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGE (PEACH) Scoreno score
ShapeROUNDSize7mm
FlavorImprint Code heart
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57344-146-011 in 1 CARTON
1180 in 1 BOTTLE, PLASTIC
2NDC:57344-146-021 in 1 CARTON
2300 in 1 BOTTLE, PLASTIC
3NDC:57344-146-031 in 1 CARTON
3100 in 1 BOTTLE, PLASTIC
4NDC:57344-146-042 in 1 CARTON
4180 in 1 BOTTLE, PLASTIC
5NDC:57344-146-05300 in 1 BOTTLE, PLASTIC
6NDC:57344-146-06500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/15/2012
Labeler - AAA Pharmaceutical, Inc. (181192162)

Revised: 12/2012
Document Id: c18169d7-dbd3-4c01-8296-e060259c32e6
Set id: c0c31523-c4c5-43c2-8d72-4d1456c720e9
Version: 1
Effective Time: 20121221
 
AAA Pharmaceutical, Inc.