ASPIRIN- aspirin tablet 
Cardinal Health

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55154-6808(NDC:0536-3305)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code TCL;011
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-6808-96 in 1 CARTON
15 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other05/24/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK

Revised: 5/2011
 
Cardinal Health