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NDC 50804-0370-12 Enteric coated aspirin 325 mg/1 Details

Enteric coated aspirin 325 mg/1

Enteric coated aspirin is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Good Sense (Geiss, Destin & Dunn, 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: 50804-0370-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Aspirin

Product Information

NDC	50804-0370
Product ID	50804-370_58fa2392-a275-49cd-990a-4fd75d84d86c
Associated GPIs	64100010000605
GCN Sequence Number	004381
GCN Sequence Number Description	aspirin TABLET DR 325 MG ORAL
HIC3	H3D
HIC3 Description	ANALGESIC/ANTIPYRETICS, SALICYLATES
GCN	16720
HICL Sequence Number	001820
HICL Sequence Number Description	ASPIRIN
Brand/Generic	Generic
Proprietary Name	Enteric coated aspirin
Proprietary Name Suffix	Regular strength
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	Good Sense (Geiss, Destin & Dunn, 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	n/a

Package

Package Images

NDC 50804-0370-12 (50804037012)

Pricing Information	N/A
NDC Package Code	50804-370-12
Billing NDC	50804037012
Package	1 BOTTLE, PLASTIC in 1 BOX (50804-370-12) / 125 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Start Date	2011-08-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f2a263f8-7d91-48c2-a27a-45c208b7bf44 Details

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

temporarily relieves minor aches and pains due to:
- headache
- toothache
- colds
- muscle pain
- menstrual pain
- minor arthritis pain
or as recommended by a doctor

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

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

gout
diabetes
arthritis

Stop use and ask a doctor if

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
- an allergic reaction occurs. Seek medical help right away
- new symptoms occur
- ringing in the ears or loss of hearing occurs
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present

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 right away.

Directions

adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist
drink a full glass of water with each dose
do not take more than 12 tablets in 24 hours unless directed by a doctor
children under 12 years of age: do not use

Other information

store at controlled room temperature 20º-25ºC (68º-77ºF)

Inactive ingredients

corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

PRINCIPAL DISPLAY PANEL

†Compare to active ingredient in Ecotrin®

Regular Strength

Enteric

Aspirin

Safety Coated

Pain Reliever (NSAID)

Aspirin Regimen**

125 Tablets (325 mg Each)

†This product is not manufactured or distributed by Prestige Brands, Inc., distributor of Ecotrin®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels.com

Product label

Goodsense Asprin 325 mg

INGREDIENTS AND APPEARANCE

ENTERIC COATED ASPIRIN REGULAR STRENGTH

aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-370
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
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	T
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50804-370-12	1 in 1 BOX	08/22/2011	01/05/2024
1		125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part343	08/22/2011	01/05/2024

Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)

Revised: 10/2021

Document Id: 58fa2392-a275-49cd-990a-4fd75d84d86c

Set id: f2a263f8-7d91-48c2-a27a-45c208b7bf44

Version: 4

Effective Time: 20211015