FDA.reportPublic FDA data

Adult Low Dose Aspirin

Manufacturer
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Effective date
2021-07-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:39:32

Label at a glance#

ProductAdult Low Dose Aspirin
Active ingredientASPIRIN
Label structure8 sections

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 hors 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

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 SECTION

Reye's syndrome:

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this products. 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 if

OTC - DO NOT USE SECTION

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 hors 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

Questions?

OTC - QUESTIONS SECTION

Adverse drug event call: (866) 562-2756

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70934-495-30

LabelLabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
70934-49570934-495-30, 70934-495-90
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
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ASPIRINR16CO5Y76EACTIB

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
c82647b3-eb85-71b8-e053-2a95a90a659aa8b07558-3371-1993-e053-2995a90a03202021-07-27WarningsExact identifier
spl id: c82647b3-eb85-71b8-e053-2a95a90a659a
spl set id: a8b07558-3371-1993-e053-2995a90a0320

Reported adverse events (FAERS/openFDA)#

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