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| Product NDC Code | 0574-7034 | ||||
|---|---|---|---|---|---|
| Drug Name | Aspirin |
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| Type | Generic | ||||
| 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 | RECTAL | ||||
| Dosage Form | SUPPOSITORY | ||||
| RxCUI drug identifier | 198464, 198473 |
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| Application Number | part343 | ||||
| Labeler Name | Padagis US LLC | ||||
| 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 Aspirin Suppositories, USP 300 mg (5 grains) Each suppository contains 300 mg (5 grains) of aspirin. OR Aspirin Suppositories, USP 600 mg (10 grains) Each suppository contains 600 mg (10 grains) of aspirin.
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 Remove suppository from plastic packet and insert into the rectum as far as possible. Adult: One suppository every 4 hours for no more than 10 days or as directed by a physician. Children under 12 years of age: Consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.ALCOHOL WARNING: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding. Manufactured by Perrigo® Minneapolis, MN 55427 Rev 05-19 B
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.Caution: Suppositories sealed in imprinted plastic packet. Do not use if imprinted packet is opened or damaged. Store in a cool place 8° - 15°C (46° - 59°F) or refrigerate.
Purpose
Information about the drug product’s indications for use.Indications: For the relief of minor aches, pains and headache and for reduction of fever.
Spl product data elements
Usually a list of ingredients in a drug product.aspirin aspirin ASPIRIN ASPIRIN HYDROGENATED PALM KERNEL OIL SILICON DIOXIDE aspirin aspirin ASPIRIN ASPIRIN HYDROGENATED PALM KERNEL OIL SILICON DIOXIDE
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.Package/Label Principal Display Panel – 300 mg NDC 0574- 7034 -12 Aspirin Suppositories, USP 300 mg (5 grains) For relief of pain and reduction of fever UNIT DOSE 12 Suppositories aspirin-300mg.JPG
Package/Label Principal Display Panel – 600 mg NDC 0574- 7036 -12 Aspirin Suppositories, USP 600 mg (10 grains) For relief of pain and reduction of fever UNIT DOSE 12 Suppositories aspirin-600mg.JPG
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 this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.
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 CHILDREN AND TEENAGERS WHO HAVE OR ARE RECOVERING FROM CHICKEN POX, FLU SYMPTOMS, OR FLU SHOULD NOT USE THIS PRODUCT. IF NAUSEA, VOMITING, OR FEVER OCCUR, CONSULT A DOCTOR BECAUSE THESE SYMPTOMS COULD BE AN EARLY SIGN OF REYE SYNDROME, A RARE BUT SERIOUS ILLNESS. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.
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