ASPIRIN- aspirin tablet 
Qualitest 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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Low Dose Aspirin 81 mg (Delayed-Release Enteric Coated)

ACTIVE INGREDIENTS (IN EACH TABLET)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever

USES

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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 very serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

if an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

Do Not Use

if you are allergic to aspirin or other pain relievers/fever reducers

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 have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

Taking a prescription drug for:

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if

  • 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
  • new symptoms occur
  • redness or swelling is present
  • Ringing in the ears or loss of hearing occurs
  • Pain gets worse or lasts for more than 10 days

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 specifically 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.

DIRECTIONS

OTHER INFORMATION

You may report side effects to: 1-888-952-0050.

INACTIVE INGREDIENTS

Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow 10, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium laurel sulfate, talc, titanium dioxide, triethyl citrate

PRINCIPAL DISPLAY PANEL

Pain Reliever

Delayed-Release Enteric Coated

Made in USA for Qualitest Pharmaceuticals

130 Vintage Drive, Huntsville, AL 35811

LowDoseAspirin81mg120ct

LowDoseAspirin81mg1000ct
ASPIRIN 
aspirin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0026
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7mm
Flavor Imprint Code A
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0603-0026-22 120 in 1 BOTTLE
2 NDC:0603-0026-32 1000 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 11/03/2009
Labeler - Qualitest Pharmaceutical, Inc. (011103059)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
Name Address ID/FEI Business Operations
A&Z Pharmaceutical, Inc. 926820705 manufacture(0603-0026) , label(0603-0026)

Revised: 2/2013
Document Id: 4e54a4e7-580a-4047-ac97-c216a2503c48
Set id: d796124e-9084-4d0d-9c4b-a9a94fc7ca0a
Version: 3
Effective Time: 20130221
 
Qualitest Pharmaceutical, Inc.