NORTH ASPIRIN  - aspirin tablet 
North Safety Products

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.

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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:

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:

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:

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

Other information

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

image of PDP

NORTH ASPIRIN  
aspirin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0498-0113
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 325 
Inactive Ingredients
Ingredient Name Strength
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED (UNII: QG4MW19XYX)  
CROSPOVIDONE (UNII: 68401960MK)  
CHOLESTERYL STEARATE (UNII: I1Q82N9DYQ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CHOLETH-20 (UNII: TTL8TE641X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Color white (White) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code FR21
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0498-0113-05 50 in 1 BOX, UNIT-DOSE
1 2 in 1 PACKET
2 NDC:0498-0113-10 100 in 1 BOX, UNIT-DOSE
2 2 in 1 PACKET
3 NDC:0498-0113-25 250 in 1 BOX, UNIT-DOSE
3 2 in 1 PACKET
4 NDC:0498-0113-50 500 in 1 BOX, UNIT-DOSE
4 2 in 1 PACKET
5 NDC:0498-0113-01 2 in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 11/07/2011
Labeler - North Safety Products (019777263)
Establishment
Name Address ID/FEI Business Operations
North Safety Products 019777263 manufacture(0498-0113) , pack(0498-0113)
Establishment
Name Address ID/FEI Business Operations
UltraTab Laboratories 151051757 manufacture(0498-0113)

Revised: 3/2013
Document Id: 8013b08a-9199-45b7-8046-1bc2c2b29d99
Set id: 1d3e8e99-62d3-4926-9eee-565e43bbfef8
Version: 7
Effective Time: 20130326
 
North Safety Products