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North Aspirin

Dosage form: tablet
Ingredients: ASPIRIN 325mg
Labeler: Honeywell Safety Products USA, Inc
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 325 mg Tablets

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses:

temporarily reduces fever and relieves minor aches and pains associated with:

  • a cold
  • headache
  • toothache
  • muscular aches
  • backache
  • minor pain of arthritis
  • premenstrual and menstrual periods

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 diabetes, gout or 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 gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • ringing in the ears or loss of hearing occurs
  • any new symptoms appear

If pregnant or breast-feeding,

If pregnant or breat-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 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 of age and older: take 1 or 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
  • children under 12 years of age: consult a doctor

Other information
  • store at room temperature 15° - 30°C (59° - 86°F)
  • TAMPER EVIDIENT PACKETS - DO NOT USE IF OPEN OR TORN

Inactive ingredients

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

*may contain these ingredients

Questions or comments?

1-800-430-5490

Honeywell Aspirin

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 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED 
STEARIC ACID 
STARCH, CORN 
POVIDONE 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSE 2208 (100 MPA.S) 
MINERAL OIL 
CELLULOSE, MICROCRYSTALLINE 
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 not finalpart34311/07/201109/18/2018
ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0114
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED 
STEARIC ACID 
STARCH, CORN 
POVIDONE 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSE 2208 (100 MPA.S) 
MINERAL OIL 
CELLULOSE, MICROCRYSTALLINE 
TITANIUM DIOXIDE 
PROPYLENE GLYCOL 
Product Characteristics
Colorwhite (White) Score2 pieces
ShapeROUNDSize10mm
FlavorImprint CodeFR21
Contains    
Packaging
#Item CodePackage Description
1NDC:0498-0114-0550 PACKET in 1 BOX
1NDC:0498-0114-012 TABLET in 1 PACKET
2NDC:0498-0114-10100 PACKET in 1 BOX
2NDC:0498-0114-012 TABLET in 1 PACKET
3NDC:0498-0114-25250 PACKET in 1 BOX
3NDC:0498-0114-012 TABLET in 1 PACKET
4NDC:0498-0114-50500 PACKET in 1 BOX
4NDC:0498-0114-012 TABLET in 1 PACKET
5NDC:0498-0114-012 TABLET in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/18/2018
Labeler - Honeywell Safety Products USA, Inc (079287321)
Establishment
NameAddressID/FEIOperations
Honeywell Safety Products USA, Inc079287321repack(0498-0113, 0498-0114)

 
Honeywell Safety Products USA, Inc

Medically reviewed on Sep 18, 2018

Further information

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

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