DrugCite

ASPIRIN - aspirin tablet, coated 
DOLGENCORP, LLC

Rexall 44-439

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains due to:
    • headache
    • muscle pain
    • toothache
    • the common cold
    • minor pain of arthrtitis
    • menstrual pain
  • or as recommended by your doctor 

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:

  • asthma (wheezing)
  • hives
  • facial swelling
  • 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 (anticoabulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxes, or others]
  • have 3 or more alcoholic drinks ever day while using this product
  • take more or for a longer time than directed

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer 

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history or 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 are

 taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away.
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

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 complication during delivery.

Keep out of reach of children

 In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and overL take 4 to 8 tablets every 4 hours, not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: do not use unless directed by a doctor 

Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • avoid excessive heat and humidity
  • see end flap for expiration date and lot number 

Inactive ingredients

 black iron oxide, cellulose, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, FD&C yellow #6, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Principal Display Panel

Since 1903

Rexall®

Enteric Safety Coated

• Low dose

• Aspirin regimen

• Easy to swallow

81mg Aspirin

Pain Reliever (NSAID)

SEE NEW WARNINGS INFORMATION

100 Coated Tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844        REV0510A43912

Visit us at: Rexall.com

or call 1-866-4-REXALL

MANUFACTURED FOR DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072 USA

439-12

439-12

 


ASPIRIN 
aspirin  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 55910-438
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
SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
HYPROMELLOSES  
POLYDEXTROSE  
POLYETHYLENE GLYCOLS  
DIMETHICONE  
SODIUM ALGINATE  
SODIUM BICARBONATE  
STEARIC ACID  
TITANIUM DIOXIDE  
TALC  
TRIACETIN  
TRIETHYL CITRATE  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 44;439
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 55910-438-12 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
1 100 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CARTON (55910-438-12)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 04/14/2004

Labeler - DOLGENCORP, LLC (068331990)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 MANUFACTURE
Revised: 08/2012DOLGENCORP, LLC