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.

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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:

  • 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

Other information

Inactive ingredients

acetylated monoglycerides, anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, hypromellose, hypromellose phthalate, iron oxide ochre, 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 - 120 Tablet Bottle Carton

RESTORE u

NDC 57344-080-01

†COMPARE TO THE ACTIVE
INGREDIENT IN BAYER®
LOW DOSE ASPIRIN

LOW DOSE

Safety
Coated

Aspirin
Pain Reliever
(NSAID)

81mg

120 ENTERIC COATED TABLETS - 81 mg each

Principal Display Panel - 120 Tablet Bottle Carton
ASPIRIN 
aspirin tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-080
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) (UNII: 87Y6436BKR)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code heart
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57344-080-01 1 in 1 CARTON
1 120 in 1 BOTTLE, PLASTIC
2 NDC:57344-080-03 1 in 1 CARTON
2 300 in 1 BOTTLE, PLASTIC
3 NDC:57344-080-04 500 in 1 BOTTLE, PLASTIC
4 NDC:57344-080-05 1000 in 1 BOTTLE, PLASTIC
5 NDC:57344-080-07 1 in 1 CARTON
5 180 in 1 BOTTLE, PLASTIC
6 NDC:57344-080-08 2 in 1 CARTON
6 120 in 1 BOTTLE, PLASTIC
7 NDC:57344-080-12 300 in 1 BOTTLE, PLASTIC
8 NDC:57344-080-13 500 in 1 BOTTLE, PLASTIC
9 NDC:57344-080-14 1 in 1 CARTON
9 32 in 1 BOTTLE, PLASTIC
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: 12/2012
Document Id: 10c8873c-bcbd-4fe5-8358-775eb9abdb8b
Set id: 609948d6-0f20-4d0c-adc0-6ae72a4f2b7a
Version: 1
Effective Time: 20121221
 
AAA Pharmaceutical, Inc.