ASPIRIN tablet, delayed release

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by INVAHEALTH INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever

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
• shock
• asthma (wheezing)

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 problem
• take a blood thinning (anticoagulant) or steroid drug
• take other drug 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
• if you have ever had an allergic reaction to this product or any of its ingredients

ASK DOCTOR

• 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 DOCTOR/PHARMACIST

• gout
• diabetes
• arthritis

STOP USE

an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:

• feel faint
• have bloody or black stools
• vomit blood
• 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
• new symptoms occur
• ringing in the ears or a loss of hearing occurs

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use. It is especially
important not to use aspirin during the last 3 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 a
Poison Control Center right away.

DOSAGE & ADMINISTRATION

• drink a full glass of water with each dose
• adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to

exceed 48 tablets in 24 hours unless directed by a doctor

• children under 12 years: consult a doctor

STORAGE AND HANDLING

• Store at room temprature. Avoid excessive heat above 40°C (104°F).

QUESTIONS

Call 1-609-642-6380 Monday through Friday 9 am to 5 pm EST

INACTIVE INGREDIENT

microcrystalline cellulose, colloidal silicon dioxide,
croscarmellose sodium, stearic acid, D&C yellow #10, D&C yellow #6 methacrylic
acid copolymer, talcum, titanium dioxide, triethyl citrate.

INDICATIONS & USAGE

for the temporary relief of minor aches and pains or as recommended by your
doctor. Because of its delayed action, this product will not provide fast
relief of headaches or other symptoms needing immediate relief.
ask your doctor about other uses for Safety Coated 81 mg Aspirin

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73376-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	I1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73376-001-50	500 in 1 BOTTLE; Type 0: Not a Combination Product	08/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	08/10/2022

Labeler - INVAHEALTH INC (116840615)