FDA.reportPublic FDA data

Adult Low Dose Aspirin

Manufacturer
A-S Medication Solutions
Effective date
2021-04-14
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-05-31 23:39:43

Label at a glance#

ProductAdult Low Dose Aspirin
Active ingredientASPIRIN
Label structure10 sections

Indications and uses

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief. ask your doctor about other uses for this product

Dosage and administration

drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not to exceed 48 tablets in 24 hours or as directed by a physician children under 12 years: consult a physician

Storage and handling

Tamper Evident: Do not use if safety seal under cap is broken or missing store at room temperature (15°-30°C) avoid excess heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain Reliever

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
  • ask your doctor about other uses for this product

Warnings

WARNINGS SECTION

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
  • asthma (wheezing)
  • facial swelling
  • 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

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • the 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:

OTC - ASK DOCTOR/PHARMACIST SECTION

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • 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
  • allergic reaction occurs
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • any new symptoms occur
  • ringing in the ears or loss of hearing occurs

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not to exceed 48 tablets in 24 hours or as directed by a physician
  • children under 12 years: consult a physician

Other information

STORAGE AND HANDLING SECTION

  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • store at room temperature (15°-30°C)
  • avoid excess heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C yellow# 10 lake, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide.

Questions? Adverse drug event call:

OTC - QUESTIONS SECTION

(866) 562-2756

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0552

NDC: 50090-0552-1 120 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 50090-0552-2 30 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 50090-0552-3 90 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 50090-0552-0 100 TABLET, DELAYED RELEASE in a BOTTLE

Aspirin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN11
308416aspirin 81 MG Delayed Release Oral TabletSCD11
308416ASA 81 MG Delayed Release Oral TabletSY11
308416aspirin 81 MG Enteric Coated Oral TabletSY11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0552-02023-01-30C16284748780-1f386c649-c6b9-0266-e053-dadaa90a7c1aDrug Facts
50090-0552-12023-01-30C16284748780-1f386c649-c6b9-0266-e053-dadaa90a7c1aDrug Facts
50090-0552-22023-01-30C16284748780-1f386c649-c6b9-0266-e053-dadaa90a7c1aDrug Facts
50090-0552-32023-01-30C16284748780-1f386c649-c6b9-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0552-0Adult Low Dose Aspirin100 in 1 BOTTLETABLET, DELAYED RELEASE10011
50090-0552-1Adult Low Dose Aspirin120 in 1 BOTTLETABLET, DELAYED RELEASE12011
50090-0552-2Adult Low Dose Aspirin30 in 1 BOTTLETABLET, DELAYED RELEASE3011
50090-0552-3Adult Low Dose Aspirin90 in 1 BOTTLETABLET, DELAYED RELEASE9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0552ADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]11Legacy NDC, 4 package rows20210416_ef9d5cea-86f1-44c2-bca4-70ff5fa16356.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0552-1EA - Each50090-05527a53cbe5-91d5-4fa1-936e-52a50e6edeec12018-09-05
50090-0552-2EA - Each50090-0552589ad717-85dd-4c1e-b150-34a302bd316612018-09-05
50090-0552-3EA - Each50090-055256678c90-bf5d-400b-bb5e-d0a6727b161912018-09-05
16103-356-09EA - Each16103-3562a4fc101-b4b3-4006-94da-4dcc4f99468a12012-07-24
16103-356-11EA - Each16103-3565401e9c5-7206-4514-b71f-0844577ed8af12012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-055250090-0552-1, 50090-0552-2, 50090-0552-3, 50090-0552-0
16103-356

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW)XRK36F13ZZIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adult Low Dose AspirinASPIRINPharbest Pharmaceuticals, Inc.4522f745-b88d-4021-a5dc-0161f1967dc92025-12-24WarningsExact identifier
ndc (product): 16103-356
a66c3f21-3582-418f-bfa9-8539c60d45aeef9d5cea-86f1-44c2-bca4-70ff5fa163562021-04-14WarningsExact identifier
spl id: a66c3f21-3582-418f-bfa9-8539c60d45ae
spl set id: ef9d5cea-86f1-44c2-bca4-70ff5fa16356

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.