DrugCite

ASPIRIN - aspirin tablet 
Cardinal Health

Drug Facts

Active ingredient

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right

away

Uses

  • temporarily relieves
  •  headache
  •  toothache  
  •  minor pain of arthritis  
  •  muscle pain
  •  pain and fever of colds  
  •  menstrual pain

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
  •  shock
  • asthma (wheezing)

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID),

which may cause stomach bleeding. The chance is higher if you:

  • _ have had stomach ulcers or bleeding problems  
  • _ take a blood-thinning (anticoagulant) or steroid drug
  • _ take other drugs containing an NSAID (ibuprofen, naproxen or others)
  • _ are age 60 or older
  • _ take more or for a longer time than directed
  • _ have 3 or more alcoholic drinks every day while using this product

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if you have

  •   problems or serious side effects from taking pain relievers or fever reducers
  •   high blood pressure
  •   stomach problems that last or come back, such as heartburn, upset stomach or stomach pain
  •   heart or kidney disease  
  •   ulcers
  •   asthma
  •   reached age 60 or older
  •   taken a diuretic
  •   bleeding problems

Ask a doctor or pharmacist before use if you are

  •   taking any other drug containing an NSAID (prescription or nonprescription)
  •   taking a blood thinning (anticoagulant) or steroid drug
  •   taking a prescription drug for diabetes, gout or arthritis
  •   taking any other drug
  •   under a doctor’s care for any serious condition

Stop use and ask a doctor if

  •   any new symptoms appear
  •   you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
  •   pain gets worse or lasts more than 10 days
  •   stomach pain or upset gets worse or lasts
  •   fever gets worse or lasts more than 3 days  
  •   redness or swelling is present in the painful area
  •   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.

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

  • adults and children 12 years and over: 1 or 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
  • children under 12 years: ask a doctor

Inactive ingredients

corn starch, croscarmellose sodium, hypromellose, microcrystalline

cellulose, mineral oil, titanium dioxide

Questions or Comments?

call 1-800-645-2158, 9 am–5 pm ET, Monday – Friday

Other Information

  •   store at 20°-25°C (68°-77°F
  •   coated for easier swallowing

Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

COMPARE TO ACTIVE INGREDIENT IN GENUINE BAYER®**

**Rugby Laboratories, Inc. is not affiliated with the owner of the trademark Genuine Bayer®.

Rugby Micro-Coated Aspirin is distributed by Rugby Laboratories, Inc.

Rugby® Duluth, GA 30097

R1008

OI80481009

Cardinal Health

Zanesville, OH 43701

Package/Label Principal Display Panel

Aspirin

Tablets 325 mg (5 gr)

Micro-Coated (NSAID)

Blister

Package/Label Principal Display Panel

Aspirin

Tablets 325 mg (5gr)

Micro-Coated (NSAID)

QTY 30

Carton

ASPIRIN 
aspirin  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 55154-6808 (0536-3305)
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
STARCH, CORN  
CROSCARMELLOSE SODIUM  
HYPROMELLOSES  
CELLULOSE, MICROCRYSTALLINE  
MINERAL OIL  
TITANIUM DIOXIDE  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code TCL;011
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 55154-6808-9 BLISTER PACK In 1 CARTON contains a BLISTER PACK
1 5 TABLET In 1 BLISTER PACK This package is contained within the CARTON (55154-6808-9)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/24/2011

Labeler - Cardinal Health (188557102)
Establishment
Name Address ID/FEI Operations
Cardinal Health 188557102 REPACK
Revised: 05/2011Cardinal Health