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NDC 00363-0397-07 Low Dose Aspirin 81 mg/1 Details

Low Dose Aspirin 81 mg/1

Low Dose Aspirin is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. 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: 00363-0397-07
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Aspirin

Product Information

NDC	00363-0397
Product ID	0363-0397_1925d855-6d2f-4190-a96f-6dd1d4aaf4f6
Associated GPIs	49270060106520
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	Low Dose 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	Walgreen Company
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 00363-0397-07 (00363039707)

Pricing Information	N/A
NDC Package Code	0363-0397-07
Billing NDC	00363039707
Package	3 BOTTLE, PLASTIC in 1 CARTON (0363-0397-07) / 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Start Date	2001-09-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fbe8ddc3-1016-4826-98e8-cea34c752cc2 Details

Active ingredient (in each chewable 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

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 problems
take a blood thinning (anticoagulant) or steroid drug
have 3 or more alcoholic drinks every day while using this product
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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
for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
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 have asthma
you are taking a diuretic

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
- have bloody or black stools
- feel faint
- 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
chew or crush tablets completely before swallowing; do not swallow tablets whole
adults and children 12 years and over: take 4 to 8 chewable tablets every 4 hours not to exceed 48 chewable 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 red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, flavor, maltodextrin, sucralose

Principal Display Panel

VALUE SIZE

NDC 0363-0397-07

Walgreens

Compare to Bayer® Chewable Low Dose Aspirin active ingredient††

Aspirin 81

81 mg CHEWABLE TABLETS

PAIN RELIEVER (NSAID)

CHEWABLE

LOW DOSE

HEART

HEALTH••

108

CHEWABLE

TABLETS

(3 BOTTLES: 36 TABLETS PER BOTTLE)

ACTUAL SIZE

CHERRY FLAVOR

Chew or crush tablets completely before swallowing. Do not swallow tablets whole.

**Talk to your doctor or other healthcare provider before using this product for your heart.

†Walgreens Pharmacist Survey

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

50844 REV1118A39707

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

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com

©2018 Walgreen Co.

44-397A

INGREDIENTS AND APPEARANCE

LOW DOSE ASPIRIN

aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0397
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
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
STARCH, CORN (UNII: O8232NY3SJ)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	8mm
Flavor	CHERRY	Imprint Code	44;397
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0397-07	3 in 1 CARTON	09/04/2001	04/14/2023
1		36 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 not final	part343	09/04/2001	04/14/2023

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0363-0397)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-0397)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0363-0397)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(0363-0397)

Revised: 9/2021

Document Id: 1925d855-6d2f-4190-a96f-6dd1d4aaf4f6

Set id: fbe8ddc3-1016-4826-98e8-cea34c752cc2

Version: 10

Effective Time: 20210909