Medication Guide App

North Aspirin

Dosage form: tablet
Ingredients: Aspirin 3251
Labeler: North Safety Products
NDC Code: 0498-0113

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

Active ingredient

Aspirin 325 mg (NSAID)

"nonsteroidal anti-inflammatory drug"

Purpose

Pain reliever/fever reducer

Uses

for the temporary relief of minor aches and pains associated with:

  • a cold
  • headache
  • toothache
  • muscular aches
  • backache - premenstrual and menstrual periods
  • minor pain from arthritis
  • and to reduce fever

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 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 steroid drug
  • take other drugs containing prescriptions 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 heartburrn
  • high blood pressure
  • heart disease
  • liver cirrhosis
  • kidney disease or are taking a diuretic
  • ulcers
  • bleeding problems
  • reached age 60 or older
  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug

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

If pregnant or breast feeding

ask a health professional before use. It is especially important not to use aspirin during the last three 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 the reach of children

In case of overdose, get medical help or  contact Poison Control Center right away.

Directions
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 or 2 tablets with water every 4 hours while symptoms persist.
  • not more than 12 tablets in 24 hours
  • children under 12 years: consult a doctor

Other information
  • store at room temperature 15o - 30o C  (59o - 86o F)
  • tamper evident packets
  • do not use if open or torn

Inactive ingredients

corn starch, povidone, silicon dioxide, stearic acid

* croscarmellose sodium, *hypromellose,* microcrystaline cellulose,*mineral oil, * polyethylene glycol

*propylene glycol,* titanium dioxide, *contains one or more of these ingredients

Questions or comments?

1-800-430-4110

Principal Display Panel

NORTH ASPIRIN  
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0113
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aspirin (Aspirin) Aspirin325 
Inactive Ingredients
Ingredient NameStrength
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED 
CROSPOVIDONE 
CHOLESTERYL STEARATE 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSE 2208 (100 MPA.S) 
LIGHT MINERAL OIL 
CELLULOSE, MICROCRYSTALLINE 
CHOLETH-20 
TITANIUM DIOXIDE 
PROPYLENE GLYCOL 
Product Characteristics
Colorwhite (White) Score2 pieces
ShapeROUNDSize10mm
FlavorImprint CodeFR21
Contains    
Packaging
#Item CodePackage Description
1NDC:0498-0113-0550 PACKET (TABLET) in 1 BOX, UNIT-DOSE
12 TABLET (TABLET) in 1 PACKET
2NDC:0498-0113-10100 PACKET (TABLET) in 1 BOX, UNIT-DOSE
22 TABLET (TABLET) in 1 PACKET
3NDC:0498-0113-25250 PACKET (TABLET) in 1 BOX, UNIT-DOSE
32 TABLET (TABLET) in 1 PACKET
4NDC:0498-0113-50500 PACKET (TABLET) in 1 BOX, UNIT-DOSE
42 TABLET (TABLET) in 1 PACKET
5NDC:0498-0113-012 TABLET (TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34311/07/2011
Labeler - North Safety Products (019777263)
Establishment
NameAddressID/FEIOperations
North Safety Products019777263manufacture(0498-0113), pack(0498-0113)
Establishment
NameAddressID/FEIOperations
UltraTab Laboratories151051757manufacture(0498-0113)

Revised: 03/2013
 
North Safety Products

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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