DrugCite

NORTH ASPIRIN   - aspirin tablet 
North Safety Products

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

image of PDP


NORTH ASPIRIN  
aspirin  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0498-0113
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Aspirin (Aspirin) Aspirin 325 
Inactive Ingredients
Ingredient Name Strength
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
Color white (White) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code FR21
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0498-0113-05 50 TABLET In 1 BOX, UNIT-DOSE contains a PACKET
1 2 TABLET In 1 PACKET This package is contained within the BOX, UNIT-DOSE (0498-0113-05)
2 0498-0113-10 100 TABLET In 1 BOX, UNIT-DOSE contains a PACKET
2 2 TABLET In 1 PACKET This package is contained within the BOX, UNIT-DOSE (0498-0113-10)
3 0498-0113-25 250 TABLET In 1 BOX, UNIT-DOSE contains a PACKET
3 2 TABLET In 1 PACKET This package is contained within the BOX, UNIT-DOSE (0498-0113-25)
4 0498-0113-50 500 TABLET In 1 BOX, UNIT-DOSE contains a PACKET
4 2 TABLET In 1 PACKET This package is contained within the BOX, UNIT-DOSE (0498-0113-50)
5 0498-0113-01 2 TABLET In 1 PACKET None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 11/07/2022

Labeler - North Safety Products (019777263)
Establishment
Name Address ID/FEI Operations
North Safety Products 019777263 manufacture, pack
Establishment
Name Address ID/FEI Operations
UltraTab Laboratories 151051757 manufacture
Revised: 03/2013North Safety Products