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Aspirin by America Medic & Science

Dosage form: tablet
Ingredients: ASPIRIN 81mg
Labeler: America Medic & Science
NDC Code: 49638-481

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.

Aspirin 81 mg Low Dose
Safety Coated Aspirin 

Drug Facts

Active ingredient (in each tablet)

Aspirin, 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

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

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

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 steriod drug
  • take other drugs containing prescription or non-prescription 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
  • taking any other drug
  • under a doctor's care for any serious condition

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 more than 10 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • ringing in the ear 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 complictions during delivery.

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

Do not use this product if printed safety seal under cap is torn or missing.

Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspiring regimen.

Directions

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.

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

anhydrous lactose, carnauba wax, iron oxide ochre, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch

Questions or comments?

call 1-855-314-1850

NDC 49638-481-36

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49638-481
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
SODIUM LAURYL SULFATE 
ANHYDROUS LACTOSE 
POLYSORBATE 80 
SODIUM HYDROXIDE 
CARNAUBA WAX 
BROWN IRON OXIDE 
DIMETHICONE 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeAP;121
Contains    
Packaging
#Item CodePackage Description
1NDC:49638-481-36365 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34301/18/2017
Labeler - America Medic & Science (071065464)
Establishment
NameAddressID/FEIOperations
TIME CAP LABORATORIES, INC037052099manufacture(49638-481)

Revised: 01/2017
 
America Medic & Science

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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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