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NDC 49483-0390-00 aspirin 81 mg/1 Details
aspirin 81 mg/1
aspirin is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Time-Cap Labs, Inc. The primary component is ASPIRIN.
MedlinePlus Drug Summary
Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused by breakdown of the lining of the joints), systemic lupus erythematosus (condition in which the immune system attacks the joints and organs and causes pain and swelling) and certain other rheumatologic conditions (conditions in which the immune system attacks parts of the body). Nonprescription aspirin is used to reduce fever and to relieve mild to moderate pain from headaches, menstrual periods, arthritis, toothaches, and muscle aches. Nonprescription aspirin is also used to prevent heart attacks in people who have had a heart attack in the past or who have angina (chest pain that occurs when the heart does not get enough oxygen). Nonprescription aspirin is also used to reduce the risk of death in people who are experiencing or who have recently experienced a heart attack. Nonprescription aspirin is also used to prevent ischemic strokes (strokes that occur when a blood clot blocks the flow of blood to the brain) or mini-strokes (strokes that occur when the flow of blood to the brain is blocked for a short time) in people who have had this type of stroke or mini-stroke in the past. Aspirin will not prevent hemorrhagic strokes (strokes caused by bleeding in the brain). Aspirin is in a group of medications called salicylates. It works by stopping the production of certain natural substances that cause fever, pain, swelling, and blood clots. Aspirin is also available in combination with other medications such as antacids, pain relievers, and cough and cold medications. This monograph only includes information about the use of aspirin alone. If you are taking a combination product, read the information on the package or prescription label or ask your doctor or pharmacist for more information.
Related Packages: 49483-0390-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Aspirin
Product Information
NDC | 49483-0390 |
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Product ID | 49483-390_7d3f7c1d-79ea-acce-e053-2a91aa0acd38 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | aspirin |
Proprietary Name Suffix | low dose enteric coated |
Non-Proprietary Name | aspirin |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 81 |
Active Ingredient Units | mg/1 |
Substance Name | ASPIRIN |
Labeler Name | Time-Cap Labs, Inc |
Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part343 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 49483-0390-00 (49483039000)
NDC Package Code | 49483-390-00 |
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Billing NDC | 49483039000 |
Package | 100000 TABLET in 1 CARTON (49483-390-00) |
Marketing Start Date | 2018-12-17 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7146c505-2469-4bc2-9e1e-ceb60951c8ae Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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, talc, titanium dioxide, triethyl citrate |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED 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 • 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 • taking a prescription drug for diabetes, gout, or arthritis • under a doctor’s care for any serious condition • taking any other drug |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
hives
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
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INGREDIENTS AND APPEARANCE
ASPIRIN
LOW DOSE ENTERIC COATED
aspirin tablet |
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Labeler - Time-Cap Labs, Inc (037052099) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Time-Cap Labs, Inc | 037052099 | manufacture(49483-390) |