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North Aspirin

Medically reviewed on December 19, 2017

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 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 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 heartburn
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • you have ulcers
  • you have bleeding problems
  • you reached age 60 or older
  • you are taking any other drug containing an NSAID (prescription or nonprescription)
  • you are 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 ringing in the ears or loss of hearing occurs, consult a doctor before taking any more of this product.

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 15 o - 30 o C (59 o - 86 o F)
  • tamper evident packets
  • do not use if open or torn

Inactive ingredients

corn starch,* croscarmellose sodium, *hypromellose,* microcrystaline cellulose,*mineral oil, * polyethylene glycol, povidone,*propylene glycol, silicon dioxide, stearic acid,* titanium dioxide

*may contain

Questions or comments?

1-800-430-5490

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 in 1 BOX, UNIT-DOSE
1NDC:0498-0113-012 TABLET in 1 PACKET
2NDC:0498-0113-10100 PACKET in 1 BOX, UNIT-DOSE
2NDC:0498-0113-012 TABLET in 1 PACKET
3NDC:0498-0113-25250 PACKET in 1 BOX, UNIT-DOSE
3NDC:0498-0113-012 TABLET in 1 PACKET
4NDC:0498-0113-50500 PACKET in 1 BOX, UNIT-DOSE
4NDC:0498-0113-012 TABLET in 1 PACKET
5NDC:0498-0113-012 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)
Registrant - North Safety Products (019777263)
Establishment
NameAddressID/FEIOperations
North Safety Products019777263repack(0498-0113)
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004pack(0498-0113)
Establishment
NameAddressID/FEIOperations
UltraTab Laboratories151051757manufacture(0498-0113)

 
North Safety Products

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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