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NDC 70000-0178-01 Adult Aspirin Regimen 81 mg/1 Details

Adult Aspirin Regimen 81 mg/1

Adult Aspirin Regimen is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. DBA Leader. 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: 70000-0178-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Aspirin

Product Information

NDC	70000-0178
Product ID	70000-0178_bb33f0df-dd50-47a5-8009-c6012689fb60
Associated GPIs	64100010000601
GCN Sequence Number	016995
GCN Sequence Number Description	aspirin TABLET DR 81 MG ORAL
HIC3	M9P
HIC3 Description	PLATELET AGGREGATION INHIBITORS
GCN	00161
HICL Sequence Number	001820
HICL Sequence Number Description	ASPIRIN
Brand/Generic	Generic
Proprietary Name	Adult Aspirin Regimen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aspirin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	81
Active Ingredient Units	mg/1
Substance Name	ASPIRIN
Labeler Name	Cardinal Health 110, LLC. DBA Leader
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 NOT FINAL
Application Number	part343
Listing Certified Through	n/a

Package

Package Images

NDC 70000-0178-01 (70000017801)

Pricing Information
NDC Package Code	70000-0178-1
Billing NDC	70000017801
Package	1 BOTTLE in 1 CARTON (70000-0178-1) / 32 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2011-05-01
NDC Exclude Flag	N
Price Per Unit	0.01455
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	ADULT ASPIRIN REGIMEN EC 81 MG
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL d4a4321f-17e6-49cd-b2a5-44b9cdf4869c Details

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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.

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
shock
facial swelling
asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
take more or for a longer time than directed
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
have 3 or more alcoholic drinks every day while using this product
are age 60 or older

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 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

gout
diabetes
arthritis

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding:
- vomit blood
- feel faint
- have bloody or black stools
- have stomach pain that does not get better
ringing in the ears or a loss of hearing occurs
pain gets worse or lasts more than 10 days
redness or swelling is present
new symptoms occur

These could be signs of a serious condition.

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 (1-800-222-1222) right away.

Directions

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: do not use unless directed by a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal display panel

LEADER™

NDC 70000-0178-3

Low Dose | Safety Coated

Adult Aspirin Regimen**

Tablets, 81 mg | Pain Reliever (NSAID)

**Talk to Your Doctor or Other Healthcare Provider Before Using This Product for Your Heart.

120

ENTERIC COATED

TABLETS

Actual Size

COMPARE TO BAYER® LOW DOSE ASPIRIN active ingredient†

100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

CIN 5528153 REV. 6/19

†This product is not manufactured or distributed by Bayer AG, owner of the registered trademark Bayer® Low Dose Aspirin.

50844 ORG031860032

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OH 43017

www.myleader.com 1-800-200-6313

100% Money Back Guarantee

Return to place of purchase.

Leader 44-600A

INGREDIENTS AND APPEARANCE

ADULT ASPIRIN REGIMEN

aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0178
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHACRYLIC ACID (UNII: 1CS02G8656)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0178-2	300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2011	06/22/2024
2	NDC:70000-0178-3	1 in 1 CARTON	05/01/2011	06/22/2024
2		120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:70000-0178-1	1 in 1 CARTON	05/01/2011	06/22/2024
3		32 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	05/01/2011	06/22/2024

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(70000-0178)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	manufacture(70000-0178) , pack(70000-0178)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(70000-0178)

Revised: 8/2022

Document Id: bb33f0df-dd50-47a5-8009-c6012689fb60

Set id: d4a4321f-17e6-49cd-b2a5-44b9cdf4869c

Version: 13

Effective Time: 20220827