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NDC 71610-0034-65 Aspirin 325 mg/1 Details
Aspirin 325 mg/1
Aspirin is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. 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: 71610-0034-65Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Aspirin
Product Information
| NDC | 71610-0034 |
|---|---|
| Product ID | 71610-034_d18746db-ee0c-4e00-b4b1-dfd10e32d1b3 |
| Associated GPIs | 64100010000605 |
| GCN Sequence Number | 004381 |
| GCN Sequence Number Description | aspirin TABLET DR 325 MG ORAL |
| HIC3 | H3D |
| HIC3 Description | ANALGESIC/ANTIPYRETICS, SALICYLATES |
| GCN | 16720 |
| HICL Sequence Number | 001820 |
| HICL Sequence Number Description | ASPIRIN |
| Brand/Generic | Generic |
| Proprietary Name | Aspirin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Aspirin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 325 |
| Active Ingredient Units | mg/1 |
| Substance Name | ASPIRIN |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| 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 71610-0034-65 (71610003465)
| NDC Package Code | 71610-034-65 |
|---|---|
| Billing NDC | 71610003465 |
| Package | 100 TABLET in 1 BOTTLE (71610-034-65) |
| Marketing Start Date | 2018-01-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 49f46b08-b2fe-4e4d-b235-983dab9740cc Details
Uses
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 signs of Reye’s syndrome, a rare but serious illness.
Allergy Alert: Aspirin may cause a severe allergic reaction which may include
- hives
- asthma (wheezing)
- shock
- facial swelling
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
- takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
- takes more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product.
Do not use
- if you have ever had an allergic reaction to any other pain reliever / fever reducer
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, lever cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout or arthritis
- taking any other drug
- under a doctor’s care for any serious condition
Stop use and ask a doctor if
- you experiences 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
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- ringing in the ears or a loss of hearing occurs
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.
Directions
Inactive Ingredients
Questions or Comments
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 325mg |
| 100 | 71610-034-65 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20180218JH
INGREDIENTS AND APPEARANCE
| ASPIRIN
aspirin tablet |
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| Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 128385585 | REPACK(71610-034) | |