TCL 481R TABLETS

Manufacturer
McKesson Corporation dba SKY Packaging | Legacy Pharmaceutical Packaging, LLC
Effective date
2025-04-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:39:40

Label at a glance#

ProductLOW DOSE ASPIRIN
Active ingredientASPIRIN
Label structure11 sections

Indications and uses

temporary relief of minor aches and pains Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for enteric-coated 81 mg Aspirin

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

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain Reliever

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of minor aches and pains

Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

  • ask your doctor about other uses for enteric-coated 81 mg Aspirin

WARNINGS

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction which may include

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock.

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

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 aspirinor any other pain reliever/fever reducer

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 are taking a diuretic
  • you have asthma
  • you have not been drinking fluids
  • you have lost a lot of fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking a prescription drug for diabetes, gout, arthritis
  • taking any other drug
  • under a doctor's care for any serious condition

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:
  • feel faint,
  • vomit blood,
  • have bloody or black stools,
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs

These could be signs of 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 specifically 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(1-800-222-1222) immediately.

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, carnauba wax, colodial sillicon dioxide, croscarmellose sodium, D&C yellow # 10 aluminum lake, iron oxide ochre, methacrylic acid and ethylacrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 63739-212

NDC: 63739-212-10 10 TABLET, COATED in a BLISTER PACK / 10 in a BOX

NDC: 63739-212-01 25 TABLET, COATED in a BLISTER PACK / 30 in a BOX

LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

LOW DOSE ASPIRIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOW DOSE ASPIRINLOW DOSE ASPIRIN

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-212LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [MCKESSON CORPORATION DBA SKY PACKAGING]6Legacy NDC20250417_1f998525-e239-4a84-9f5e-9cc27c96f522.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-212-01EA - Each63739-2120d5e56f1-2f7c-4c97-9d6b-cc04bf6224ca12020-03-10
63739-212-02EA - Each63739-2122280cbd1-9174-4646-9859-54ec0b1c506512021-06-02
63739-212-10EA - Each63739-2121ec12e06-3c5c-4c71-91e8-c372d043f26612020-03-10
49483-481-10EA - Each49483-48168c3b475-b23b-4a98-95f3-b88442ecc38e12017-06-15
49483-481-12EA - Each49483-4816d406952-771a-4b61-979e-0a5c9475bf6112017-06-15

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
63739-21263739-212-10, 63739-212-01, 63739-212-02
49483-481

Ingredients#

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

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

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
32d732b8-6e14-f10c-e063-6394a90ad7351f998525-e239-4a84-9f5e-9cc27c96f5222025-04-15WarningsExact identifier
spl id: 32d732b8-6e14-f10c-e063-6394a90ad735
spl set id: 1f998525-e239-4a84-9f5e-9cc27c96f522
LOW DOSE ASPIRINASPIRINTIME CAP LABORATORIES, INC1acc8c1a-c746-4635-800c-de1ad758fce02023-12-30WarningsExact identifier
ndc (product): 49483-481

Reported adverse events (FAERS/openFDA)#

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