Your browser does not support JavaScript! ASPIRIN TABLET [HART HEALTH]
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ASPIRIN tablet
[HART Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Aspirin (NSAID)* 325mg (*non-steroidal anti-inflammatory drug)

Uses:

Temporarily relieves minor aches and pains due to:

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

Temporarily reduces fever

Warnings:

Reye's Syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin

Allergy altert: Aspirin may cause a several allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

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 ulers or bleeding problems
  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, others)

Do not use if you have ever had an allergic reaction to 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 are taking a diuretic
  • you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease

Ask a doctor or pharmacist before use if you:

  • take any other drug containing an NSAID
  • take a blood thinning (anticoagulant) or steroid drug
  • take any drug for diabetes, gout, or arthritis

Stop use and ask a doctor if:

  • an allergic reaction occurs, seek medical help right away
  • fever gets worse or lasts more than 3 days
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present in the painful area
  • new symptoms occur
  • you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better

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: Do not take more than directed.

Adults and children 12 years of age and over:

  • take 1 or 2 tablets with water every 4 hours while symptoms persist
  • do not take more than 12 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

Inactive Ingredients: Corn Starch, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Titanium Dioxide

Aspirin.jpg

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50332-0102
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code TCL011
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0102-450 in 1 BOX, UNIT-DOSE
12 in 1 PACKET
2NDC:50332-0102-7125 in 1 BOX, UNIT-DOSE
22 in 1 PACKET
3NDC:50332-0102-8250 in 1 BOX, UNIT-DOSE
32 in 1 PACKET
4NDC:50332-0102-1500 in 1 BOX, UNIT-DOSE
42 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34306/04/1986
Labeler - HART Health (069560969)

Revised: 10/2012
 
HART Health

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