FDA.reportPublic FDA data

Adult Low Dose Aspirin Enteric Coated

Manufacturer
Pharbest Pharmaceuticals, Inc.
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:28:22

Label at a glance#

ProductAdult Low Dose Aspirin Enteric Coated
Active ingredientASPIRIN
Label structure9 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 will 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 not to exceed 48 tablets in 24 hours unless directed by a doctor  Children under 12 years  consult a doctor

Storage and handling

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

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 will 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
  • facial swelling
  • asthma (wheezing)
  • 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 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for:

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

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 not to exceed 48 tablets in 24 hours unless directed by a doctor
 Children under 12 years consult a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C Yellow# 10 Lake, FD&C Yellow #6, hypromellose, lactose, methacrylic acid copolymer, microcrystalline cellulose, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, starch, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 Mon - Fri 8 AM to 4 PM 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 16103-351-16

Manufactured in the USA

*Compare to the active ingredient in Bayer® Low Dose

Adult Low Dose

Aspirin

ENTERIC COATED

81mg

Aspirin 81 mg

Pain Reliever (NSAID)

EA8

1000 TABLETS

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

Adult low Dose Aspirin 81 mg Enteric Coated (EA8) tablet Product LabelAdult low Dose Aspirin 81 mg Enteric Coated (EA8) tablet Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN4
308416aspirin 81 MG Delayed Release Oral TabletSCD4
308416ASA 81 MG Delayed Release Oral TabletSY4
308416aspirin 81 MG Enteric Coated Oral TabletSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
16103-351-092024-12-31C16284748780-1f386c649-f950-0266-e053-dadaa90a7c1aDrug Facts
16103-351-112024-12-31C16284748780-1f386c649-f950-0266-e053-dadaa90a7c1aDrug Facts
16103-351-162024-12-31C16284748780-1f386c649-f950-0266-e053-dadaa90a7c1aDrug Facts
16103-351-092023-01-30C16284748780-1f386c649-f950-0266-e053-dadaa90a7c1aDrug Facts
16103-351-112023-01-30C16284748780-1f386c649-f950-0266-e053-dadaa90a7c1aDrug Facts
16103-351-162023-01-30C16284748780-1f386c649-f950-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-351-09Adult Low Dose Aspirin Enteric Coated120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1204
16103-351-11Adult Low Dose Aspirin Enteric Coated1000 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE10004
16103-351-16Adult Low Dose Aspirin Enteric Coated300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3004

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16103-35116103-351-09, 16103-351-16, 16103-351-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)XRK36F13ZZIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STARCH, CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TRIETHYL CITRATE8Z96QXD6UMIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adult Low Dose Aspirin Enteric CoatedASPIRIN 81MGPharbest Pharmaceuticals, Inc.45e5bae9-22a7-4699-85ea-5b922af6b96d2025-12-24WarningsExact identifier
ndc (package): 16103-351-09
ndc (package): 16103-351-11
ndc (package): 16103-351-16
ndc (product): 16103-351
ndc11 (package): 16103035109
ndc11 (package): 16103035116
ndc11 (package): 16103035111
spl id: 45b929af-8d23-4414-9c47-fe92e6c7e9af
spl set id: 45e5bae9-22a7-4699-85ea-5b922af6b96d

Reported adverse events (FAERS/openFDA)#

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