Aspir Low

Dosage form: tablet
Ingredients: ASPIRIN 81mg
Labeler: Cardinal Health
NDC Code: 55154-0747

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.

Drug Facts

Active ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

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 minor aches and pains

■ for other uses, see your doctor, but do not use for more than 10 days without consulting your

doctor because serious side effects may occur

Warnings

Reyeʼs syndrome: Children and teenagers who have or are recovering from chicken pox or flulike

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 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 (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 ■ you have asthma

■ you have not been drinking fluids ■ you have lost a lot of fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are

■ taking a prescription drug for diabetes, gout, or arthritis

■ under a doctor’s care for any serious condition ■ taking any other drug

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

■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days

■ redness or swelling is present in the painful area ■ any new symptoms appear

■ ringing in the ears or a 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: 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: consult a doctor

Inactive ingredients

anhydrous lactose, carnauba wax, colloidal silicon dioxide,

croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid

copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium

lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions?

Adverse Drug Event Call: (800) 616-2471

Other Information

■ store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

■ use by expiration date on package

**Compare to the active ingredient in BAYER® Low Dose

**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered

trademark Bayer® Low Dose. 387R 0610

Distributed by Major Pharmaceuticals

31778 Enterprise Drive,

Livonia, MI 48150 USA

 ASPIR LOW™

LOW STRENGTH 81mg ASPIRIN (NSAID)

Enteric Coated

1 1/4 gr. (81 mg) each Analgesic

SEE NEWWARNINGS INFORMATION

NEWTablet Appearance

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

MAJOR®

OI80410910

Cardinal Health

Zanesville, OH 43701

Package/Label Principal Display Panel

Aspir Low

1 1/4 gr. (81 mg) (NSAID)

Enteric Coated Tablets

Carton

Aspir Low

81 mg Aspirin (NSAID)

Enteric Coated

1 1/4 gr. (81 mg) each Analgesic

QTY 30

ASPIR LOW 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0747(NDC:0904-7704)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FERRIC OXIDE YELLOW 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
DIMETHICONE 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-0747-96 BLISTER PACK (BLISTER PACK) in 1 CARTON
15 TABLET (TABLET) 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/FEIOperations
Cardinal Health188557102REPACK

Revised: 05/2011
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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