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NDC 60760-0071-24 HEALTH SENSE ECPIRIN 325 mg/1 Details

HEALTH SENSE ECPIRIN 325 mg/1

HEALTH SENSE ECPIRIN is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by St. Mary's Medical Park Pharmacy. The primary component is ASPIRIN.

MedlinePlus Drug Summary

Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused by breakdown of the lining of the joints), systemic lupus erythematosus (condition in which the immune system attacks the joints and organs and causes pain and swelling) and certain other rheumatologic conditions (conditions in which the immune system attacks parts of the body). Nonprescription aspirin is used to reduce fever and to relieve mild to moderate pain from headaches, menstrual periods, arthritis, toothaches, and muscle aches. Nonprescription aspirin is also used to prevent heart attacks in people who have had a heart attack in the past or who have angina (chest pain that occurs when the heart does not get enough oxygen). Nonprescription aspirin is also used to reduce the risk of death in people who are experiencing or who have recently experienced a heart attack. Nonprescription aspirin is also used to prevent ischemic strokes (strokes that occur when a blood clot blocks the flow of blood to the brain) or mini-strokes (strokes that occur when the flow of blood to the brain is blocked for a short time) in people who have had this type of stroke or mini-stroke in the past. Aspirin will not prevent hemorrhagic strokes (strokes caused by bleeding in the brain). Aspirin is in a group of medications called salicylates. It works by stopping the production of certain natural substances that cause fever, pain, swelling, and blood clots. Aspirin is also available in combination with other medications such as antacids, pain relievers, and cough and cold medications. This monograph only includes information about the use of aspirin alone. If you are taking a combination product, read the information on the package or prescription label or ask your doctor or pharmacist for more information.

Related Packages: 60760-0071-24
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Aspirin

Product Information

NDC	60760-0071
Product ID	60760-071_903d4fdd-879d-9858-e053-2a95a90a11a1
Associated GPIs	64100010000605
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	HEALTH SENSE ECPIRIN
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aspirin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
Route	ORAL
Active Ingredient Strength	325
Active Ingredient Units	mg/1
Substance Name	ASPIRIN
Labeler Name	St. Mary's Medical Park Pharmacy
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part343
Listing Certified Through	2022-12-31

Package

Package Images

NDC 60760-0071-24 (60760007124)

Pricing Information	N/A
NDC Package Code	60760-071-24
Billing NDC	60760007124
Package	24 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-071-24)
Marketing Start Date	2019-08-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 903d4fdd-879c-9858-e053-2a95a90a11a1 Details

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID-nonsteroidal anti-inflammatory drug)

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains
ask your doctor about other uses for aspirin

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

the stomach bleeding warning applies to you
you are taking a diuretic
you have a history of stomach problems, such as heartburn
you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

taking any other drug containing an NSAID (prescription or nonprescription)
taking a blood thinning (anticoagulant) or steroid drug
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
an allergic reaction occurs. Seek medical help right away
pain gets worse or lasts more than 10 days
redness or swelling is present
fever gets worse or lasts more than 3 days
any new symptoms occur
ringing in the ears or loss of hearing occurs

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.

Directions

drink a full glass of water with each dose
swallow whole, do not chew or crush
do not exceed recommended dose
adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor
children under 12 years: ask a doctor

Other information

store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)

Inactive ingredients

cellulose, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, silica, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALTH SENSE ECPIRIN

aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60760-071(NDC:62107-028)
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
DIMETHICONE (UNII: 92RU3N3Y1O)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	44;227
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60760-071-24	24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/15/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part343	08/15/2019

Labeler - St. Mary's Medical Park Pharmacy (063050751)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Name	Address	ID/FEI	Business Operations
Establishment
St Mary's Medical Park Pharmacy		063050751	relabel(60760-071) , repack(60760-071)

Name	Address	ID/FEI	Business Operations
Establishment
Geri-Care Pharmaceutical Corp		611196254	manufacture(60760-071) , repack(60760-071)

Revised: 8/2019

Document Id: 903d4fdd-879d-9858-e053-2a95a90a11a1

Set id: 903d4fdd-879c-9858-e053-2a95a90a11a1

Version: 1

Effective Time: 20190816