DrugCite

ASPIRIN - aspirin tablet, film coated 
Contract Pharmacy Services-PA

Aspirin Tablets

DRUG FACTS

ACTIVE INGREDIENT (IN EACH TABLET)

Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USES

Temporarily relieves minor aches and pains associated with

  • headache
  • minor arthritis
  • common cold
  • menstrual cramps
  • muscular aches
  • backache
  • toothache

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
  • asthma (wheezing)
  • shock

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 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 of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic

Ask a doctor or pharmacist before use if

taking a prescription drug for diabetes, gout or 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
  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs

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.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

  • do not take more than directed
  • the smallest effective dose should be used
  • do not take longer than 10 days, unless
    directed by a doctor (see Warnings)
  • drink a full glass of water with each dose

Adults and childre: (12 years and older)

Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years:

Do not give to children under 12 years of age.

OTHER INFORMATION

store at 15° to 30°C (59° to 86°F)

Inactive Ingredients

ma contain acetylated monoglycerides, cellulose, croscarmellose sodium, D&C yellow #10 lake, FD&C yellow lake #6, hypromellose, hypromellose phthalate, iron oxide, methacrylic acid, mineral oil, PEG, polydextrose, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium bicarbonate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax.

QUESTIONS OR COMMENTS?

Distributed by:

GERI-CARE PHARMACEUTICALS CORP.

1650 63 Street, Brooklyn, New York 11204

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--08/2010--NJW

Package Label

Blister of 30 Tablets

Blister of 30 Tablets


ASPIRIN 
aspirin  tablet, film coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 67046-164 (57896-921)
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
POWDERED CELLULOSE  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
HYPROMELLOSES  
FERRIC OXIDE RED  
METHACRYLIC ACID  
MINERAL OIL  
POLYDEXTROSE  
POLYSORBATE 80  
PROPYLENE GLYCOL  
SILICON DIOXIDE  
SODIUM ALGINATE  
SODIUM BICARBONATE  
SODIUM LAURYL SULFATE  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
TRIETHYL CITRATE  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 44;227
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 67046-164-30 30 TABLET In 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 11/01/2010

Labeler - Contract Pharmacy Services-PA (945429777)
Revised: 11/2010Contract Pharmacy Services-PA