NORTH ASPIRIN- aspirin tablet ASPIRIN tablet

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, NORTH SAFETY DE MEXICALI, S. DE R.I. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

Honeywell Aspirin

INGREDIENTS AND APPEARANCE

NORTH ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-0113
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MINERAL OIL (UNII: T5L8T28FGP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
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	11/07/2011	09/18/2018
1	NDC: 0498-0113-01	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0498-0113-10	100 in 1 BOX, UNIT-DOSE	11/07/2011	09/18/2018
2	NDC: 0498-0113-01	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0498-0113-25	250 in 1 BOX, UNIT-DOSE	11/07/2011	09/18/2018
3	NDC: 0498-0113-01	2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0498-0113-50	500 in 1 BOX, UNIT-DOSE	11/07/2011	09/18/2018
4	NDC: 0498-0113-01	2 in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 0498-0113-01	2 in 1 PACKET; Type 0: Not a Combination Product	11/07/2011	09/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/07/2011	09/18/2018

ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0498-0114
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
MINERAL OIL (UNII: T5L8T28FGP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
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: 0498-0114-05	50 in 1 BOX	09/18/2018
1	NDC: 0498-0114-01	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 0498-0114-10	100 in 1 BOX	09/18/2018
2	NDC: 0498-0114-01	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 0498-0114-25	250 in 1 BOX	09/18/2018
3	NDC: 0498-0114-01	2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 0498-0114-50	500 in 1 BOX	09/18/2018
4	NDC: 0498-0114-01	2 in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 0498-0114-01	2 in 1 PACKET; Type 0: Not a Combination Product	09/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/18/2018

Labeler - Honeywell Safety Products USA, Inc (079287321)

Establishment
Name	Address	ID/FEI	Business Operations
Honeywell Safety Products USA, Inc		079287321	repack(0498-0113, 0498-0114)