Low Dose Miniprin Enteric Safety Coated

Dosage form: tablet, delayed release
Ingredients: ASPIRIN 81mg
Labeler: Time-Cap Labs, Inc
NDC Code: 49483-330

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.

DRUG FACTS

Active ingredient (in each tablet)                   Purpose
Aspirin 81 mg (NSAID*)................................Pain reliever
*nonsteroidal anti-inflammatory drug

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

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:
  • 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
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

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
  • taking any other drug
  • under a doctor's care for any serious condition

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.

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

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

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

LOW DOSE MINIPRIN  ENTERIC SAFETY COATED
aspirin tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-330
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Codeembossed;upper;8;lower;plain
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-330-12120 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE, PLASTIC
2NDC:49483-330-101000 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34308/11/2010
Labeler - Time-Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIOperations
Time-Cap Labs, Inc037052099manufacture

Revised: 08/2010
 
Time-Cap Labs, Inc

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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