CARE ONE ASPIRIN- aspirin tablet 
American Sales Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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American Sales Company Aspirin Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

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

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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
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 have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

you have asthma
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 you are

taking a prescription drug for

diabetes
gout
arthritis

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.
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
fever lasts for more than 3 days
ringing in the ears or loss of hearing occurs
redness or swelling is present
any new symptoms occur

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 complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 1 or 2 tablets every 4 hours; do not exceed 12 tablets in 24 hours
children under 12 years: ask a doctor

Other information

store at 20º-25ºC (68º-77ºF)

Inactive ingredients

dicalcium phosphate dihydrate, glyceryl triacetate, hypromellose, starch, talc

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Bayer® Aspirin

Regular Strength

ASPIRIN

PAIN RELIEVER/FEVER REDUCER (NSAID)

Fast, Safe Pain Relief

See New Warnings Information

325 mg

Aspirin Label Image 1

Aspirin Label Image 1

Aspirin Label Image 2

Aspirin Label Image 1

Aspirin Label Image 2

CARE ONE ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-416
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
TRIACETIN (UNII: XHX3C3X673)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TALC (UNII: 7SEV7J4R1U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize14mm
FlavorImprint Code Aspirin;L
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-416-78100 in 1 BOTTLE; Type 0: Not a Combination Product05/18/200402/27/2013
2NDC:41520-416-87300 in 1 BOTTLE; Type 0: Not a Combination Product05/18/200402/27/2013
3NDC:41520-416-90500 in 1 BOTTLE; Type 0: Not a Combination Product05/18/200402/27/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/18/200402/27/2013
Labeler - American Sales Company (809183973)

Revised: 11/2017
 
American Sales Company