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NDC 68788-7792-01 Adult Low Dose Enteric Coated Aspirin 81 mg/1 Details
Adult Low Dose Enteric Coated Aspirin 81 mg/1
Adult Low Dose Enteric Coated Aspirin is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Preferred Pharmaceuticals 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: 68788-7792-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Aspirin
Product Information
| NDC | 68788-7792 |
|---|---|
| Product ID | 68788-7792_fd2a7503-2830-46f8-a588-f1e1d156b618 |
| 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 | Adult Low Dose Enteric Coated Aspirin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Aspirin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 81 |
| Active Ingredient Units | mg/1 |
| Substance Name | ASPIRIN |
| Labeler Name | Preferred Pharmaceuticals 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 | 2023-12-31 |
Package
Package Images
NDC 68788-7792-01 (68788779201)
| NDC Package Code | 68788-7792-1 |
|---|---|
| Billing NDC | 68788779201 |
| Package | 100 TABLET, COATED in 1 BOTTLE (68788-7792-1) |
| Marketing Start Date | 2020-10-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7d3ff4e7-1126-46fe-b6a6-8737c8e2cb3e 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 sign of Reye's syndrome, a rare but serious illness.
Allergy Alert: Aspirin may cause a severe allergic reaction which may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product
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- take more or for a longer time than directed
Do not use if your are allergic to aspirin or any other pain reliever/fever reducer.
Ask a doctor before use if
- •
- the stomach bleeding warning applies to you
- •
- you are taking a diuretic
- •
- you have a history of stomach problems, such as heartburn
- •
- you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma
Ask a doctor or pharmacist before use if you are
- •
- taking any other drug containing an NSAID (prescription or nonprescription)
- •
- taking a blood thinning (anticoagulant) or steroid drug
- •
- taking a prescription drug for diabetes, gout or arthritis
Stop use and ask a doctor if
- •
- 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
- •
- an allergic reaction occurs. Seek medical help right away
- •
- pain gets worse or lasts more than 10 days
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- redness or swelling is present
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- fever gets worse or lasts more than 3 days
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- any new symptoms occur
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- ringing in the ears or 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.
Directions
- •
- drink a full glass of water with each dose
- •
- swallow whole, do not chew or crush
- •
- do not exceed recommended dose
- •
- adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
- •
- children under 12 years: ask a doctor
Other information
Inactive ingredients
cellulose, D &C yellow
#10, FD&C yellow #6, hypromellose, iron oxide,
methacrylic acid, PEG, polydextrose, propylene
glycol, silica, simethicone, sodium bicarbonate,
sodium lauryl sulfate, starch, talc, titanium dioxide,
triacetin, triethyl citrate, wax. May also contain:
acetylated monoglycerides, croscarmellose sodium,
hypromellose phthalate, lactose, mineral oil,
polysorbate 80, stearic acid.
Repackaged By: Preferred Pharmaceuticals Inc.
package label
INGREDIENTS AND APPEARANCE
| ADULT LOW DOSE ENTERIC COATED ASPIRIN
aspirin tablet, coated |
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| Labeler - Preferred Pharmaceuticals Inc. (791119022) |
| Registrant - Preferred Pharmaceuticals Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Preferred Pharmaceuticals Inc. | 791119022 | REPACK(68788-7792) | |