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Adults Low Strength Aspirin

Medically reviewed on June 1, 2018

Dosage form: tablet
Ingredients: ASPIRIN 81mg
Labeler: Genvion Corporation
NDC Code: 62049-001

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.

Adult's Low Strength Aspirin

Drug Facts

Active ingredient (in each tablet)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses
  • temporarily relieves minor aches and pains
  • Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief

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
  • 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 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

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if
  • 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 lasts for more than 10 days
  • pain persists or gets worse
  • new symptoms occur
  • redness or swelling is present
  • ringing in the ear or loss of hearing occurs. 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

Directions
  • do not exceed recommended dosage
  • drink a full glass of water with each dose
  • adults and children 12 years of age and older: take 4 to 8 tablets every 4 hours not to exceed 49 tablets in 24 hours, or as directed by a doctor
  • children under 12 years of age: consult a doctor

Other information

Store at controlled room temperature 15º - 30ºC (59º - 86ºF)

Inactive ingredients

hydrophilic pyrogenic silica, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, sodium starch glycolate, pregelatinized starch (Starch 1500), talc, titanium dioxide, triacetin, triethyl citrate

Questions?

For questions regarding this product, please contact 1-204-663-2866

Package Labeling

ADULTS LOW STRENGTH ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62049-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
sodium bicarbonate 
sodium lauryl sulfate 
talc 
titanium dioxide 
triacetin 
triethyl citrate 
Product Characteristics
Colorblue (blue) Scoreno score
ShapeROUND (round) Size8mm
FlavorImprint CodeC;
Contains    
Packaging
#Item CodePackage Description
1NDC:62049-001-00100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/01/2015
Labeler - Genvion Corporation (245221226)
Establishment
NameAddressID/FEIOperations
Genvion Corporation245221226manufacture(62049-001)

 
Genvion Corporation

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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