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NDC 68788-7794-01 Regular Strength Enteric coated aspirin 325 mg/1 Details
Regular Strength Enteric coated aspirin 325 mg/1
Regular Strength 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.
Product Information
| NDC | 68788-7794 |
|---|---|
| Product ID | 68788-7794_fe421104-5b53-4d86-9d54-8d75905346f2 |
| 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 | Regular Strength 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 | 325 |
| 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 NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 68788-7794-01 (68788779401)
| NDC Package Code | 68788-7794-1 |
|---|---|
| Billing NDC | 68788779401 |
| Package | 20 TABLET, COATED in 1 BOTTLE (68788-7794-1) |
| Marketing Start Date | 2020-10-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a1d09165-6ad7-4430-928f-1b6470dbdd4a 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:
- •
- hives
- •
- 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 you 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
- •
- 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 1-2 tablets every 4 hours, as needed, not more than 12 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 lake, FD&C yellow #6 lake, hypromellose, iron
oxide, PEG, polydextrose, polyvinyl acetate phthalate,
propylene glycol, shellac wax, silica, simethicone,
sodium alginate, sodium bicarbonate, starch, stearic
acid, talc, titanium dioxide, triacetin, triethyl citrate.
May also contain acetylated monoglycerides,
croscarmellose sodium, hypromellose phthalate,
methacrylic acid, mineral oil, polysorbate 80, sodium
lauryl sulfate.
package label
INGREDIENTS AND APPEARANCE
| REGULAR STRENGTH 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(68788-7794) | |