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| Product NDC Code | 71335-0513 | ||||||||||||||||||
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| Drug Name | Regular strength enteric coated aspirin |
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| Type | Brand | ||||||||||||||||||
| Pharm 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] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||||||
| Dosage Form | TABLET, COATED | ||||||||||||||||||
| RxCUI drug identifier | 198467 | ||||||||||||||||||
| Application Number | M013 | ||||||||||||||||||
| Labeler Name | Bryant Ranch Prepack | ||||||||||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Aspirin 325 mg(NSAID)* *nonsteroidal anti-inflammatory drug
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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: do not use unless directed by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients black iron oxide, cellulose, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, silicon dioxide, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for the temporary relief of minor aches and pains ask your doctor about other uses for aspirin
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.Regular Strength Enteric coated aspirin Aspirin FERROSOFERRIC OXIDE STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED POLYVINYL ACETATE PHTHALATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE STEARIC ACID SODIUM BICARBONATE SODIUM ALGINATE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE DIMETHICONE ASPIRIN ASPIRIN 44;227
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Aspirin E.C 325 mg Tablet Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-540-3765
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Aspirin 325 mg(NSAID)* *nonsteroidal anti-inflammatory drug. NDC: 71335-0513-1: 30 Tablets in a BOTTLE NDC: 71335-0513-2: 60 Tablets in a BOTTLE NDC: 71335-0513-3: 100 Tablets in a BOTTLE NDC: 71335-0513-4: 90 Tablets in a BOTTLE NDC: 71335-0513-5: 20 Tablets in a BOTTLE NDC: 71335-0513-6: 45 Tablets in a BOTTLE NDC: 71335-0513-7: 120 Tablets in a BOTTLE NDC: 71335-0513-8: 7 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 asthma (wheezing) shock 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 Do not use if you are allergic to aspirin or any other pain reliever/fever reducer if you ever had an allergic reaction to this product or any of its ingredients 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 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 redness or swelling is present fever gets worse or lasts more than 3 days any new symptoms occur 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 at 20 weeks or later in 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API