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NDC 54738-0128-36 Aspirin 81 mg/1 Details

Aspirin 81 mg/1

Aspirin is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Richmond Pharmaceuticals, Inc.. 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: 54738-0128-36
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Aspirin

Product Information

NDC	54738-0128
Product ID	54738-128_5cc44dca-00c9-b589-e053-2a91aa0a0521
Associated GPIs	64100010000510
GCN Sequence Number	004380
GCN Sequence Number Description	aspirin TAB CHEW 81 MG ORAL
HIC3	M9P
HIC3 Description	PLATELET AGGREGATION INHIBITORS
GCN	16713
HICL Sequence Number	001820
HICL Sequence Number Description	ASPIRIN
Brand/Generic	Generic
Proprietary Name	Aspirin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Aspirin
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	81
Active Ingredient Units	mg/1
Substance Name	ASPIRIN
Labeler Name	Richmond Pharmaceuticals, Inc.
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	2024-12-31

Package

Package Images

NDC 54738-0128-36 (54738012836)

Pricing Information	N/A
NDC Package Code	54738-128-36
Billing NDC	54738012836
Package	36 TABLET, CHEWABLE in 1 BOTTLE (54738-128-36)
Marketing Start Date	2015-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6a4c897d-c2a8-41b8-98b7-e7da8e2819ec Details

Active Ingredient

(in each tablet)

Aspirin 81 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Use

temporarily relieves minor aches and pains
for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effect may occur.

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 signs of Reye’s syndrome, a rare but serious illness.

Allergy Alert: Aspirin may cause a severe allergic reaction which may include

hives
asthma (wheezing)
shock
facial swelling
Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child
has had stomach ulcers or bleeding problems
take a blood-thinning (anticoagulant) or steroid drug
takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
takes more or for a longer time than directed
Do not use
if the child has ever had an allergic reaction to any other pain reliever / fever reducer
for at least 7 days after tonsillectomy or oral surgery
Ask a doctor before use if
stomach bleeding warning applies to your child
child has a history of stomach problems, such as heartburn
child has not been drinking fluids
child has lost a lot of fluid due to vomiting and diarrhea
child has high blood pressure, heart disease, lever cirrhosis, or kidney disease
child is taking a diuretic
child has asthma
Ask a doctor or pharmacist before use if the child is
taking a prescription drug for diabetes, gout or arthritis
taking any other drug
under a doctor’s care for any serious condition
Stop use and ask a doctor if
child experiences any of the following signs of stomach bleeding:
feels faint
vomits blood
has bloody or black stools
has stomach pain that does not get better
pain gets worse or lasts more than 5 days
any new symptoms appear
redness or swelling is present in the painful area
ringing in the ears or a 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
adults and children 12 years and older : take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours.
Children under 12 years: ask a doctor

Other Information

store at 15-30 °C (59-86 °F)

Inactive Ingredients

corn starch, FD&C Yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide, sugar

Questions or Comments

Call 804-270-4498, 8.30am – 4.30 pm ET Monday-Friday

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 54738-128-36 – 36 COUNT

INGREDIENTS AND APPEARANCE

ASPIRIN

aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54738-128
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ORANGE (UNII: 5EVU04N5QU)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	8mm
Flavor	ORANGE	Imprint Code	AP;009
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54738-128-36	36 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part343	04/01/2015

Labeler - Richmond Pharmaceuticals, Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(54738-128)

Revised: 10/2017

Document Id: 5cc44dca-00c9-b589-e053-2a91aa0a0521

Set id: 6a4c897d-c2a8-41b8-98b7-e7da8e2819ec

Version: 2

Effective Time: 20171030