481R-TCL-49483-481 ASPIRIN 81MG DELAYED RELEASE TABLETS
- Manufacturer
- Bryant Ranch Prepack
- Effective date
- 2024-01-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 102
- Source
- full-release
- Hydrated at
- 2026-06-01 00:07:34
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose
Pain reliever
INDICATIONS & USAGE SECTION
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 headaches or other symptoms needing immediate relief.
ask your doctor about other uses for enteric-coated 81 mg Aspirin
WARNINGS SECTION
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
- 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
OTC - DO NOT USE SECTION
Do not use
- 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
OTC - ASK DOCTOR SECTION
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 are taking a diuretic
- you have asthma
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking a prescription drug for:
- diabetes
- gout
- arthritis
OTC - STOP USE SECTION
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
have bloody or black stools
vomit blood
have stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- ringing in the ears or a loss of hearing occurs
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- 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
Other information
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
- avoid excessive heat above 40°C (104°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate
OTC - QUESTIONS SECTION
Questions? Call 1-877-290-4008
HOW SUPPLIED
NDC: 63629-8875-1: 1000 Tablets in a BOTTLE, PLASTIC
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-8875-1 | LOW DOSE ASPIRIN | 1000 in 1 BOTTLE, PLASTIC | TABLET, COATED | 1000 | 102 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-8875 | LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [BRYANT RANCH PREPACK] | 102 | Current NDC, Legacy NDC, 1 package rows | 20240119_64c28b38-23bb-4c7e-9c19-1d1f0d597528.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-8875-1 | EA - Each | 63629-8875 | 2751529b-50c5-45f0-ba9d-3939e6df2aa4 | 1 | 2021-12-08 |
| 49483-481-10 | EA - Each | 49483-481 | 68c3b475-b23b-4a98-95f3-b88442ecc38e | 1 | 2017-06-15 |
| 49483-481-12 | EA - Each | 49483-481 | 6d406952-771a-4b61-979e-0a5c9475bf61 | 1 | 2017-06-15 |
Products#
Every source-derived product name is available through these pages.
- LOW DOSE ASPIRIN
- ASPIRIN
- SODIUM HYDROXIDE
- ANHYDROUS LACTOSE
- CARNAUBA WAX
- SILICON DIOXIDE
- D&C YELLOW NO. 10 ALUMINUM LAKE
- BROWN IRON OXIDE
- METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
- POLYSORBATE 80
- DIMETHICONE
- SODIUM LAURYL SULFATE
- STARCH, CORN
- TALC
- TITANIUM DIOXIDE
- TRIETHYL CITRATE
- MICROCRYSTALLINE CELLULOSE
- CROSCARMELLOSE SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63629-8875 | 63629-8875-1 |
| 49483-481 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LOW DOSE ASPIRIN | ASPIRIN | Bryant Ranch Prepack | 64c28b38-23bb-4c7e-9c19-1d1f0d597528 | 2024-01-18 | Warnings | 63629-8875-1 63629-8875 63629887501 5bd54047-fc5c-43a8-9f1b-b0517eef10b8 64c28b38-23bb-4c7e-9c19-1d1f0d597528 |
| LOW DOSE ASPIRIN | ASPIRIN | TIME CAP LABORATORIES, INC | 1acc8c1a-c746-4635-800c-de1ad758fce0 | 2023-12-30 | Warnings | 49483-481 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
