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| Product NDC Code | 81533-600 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Nobleaid pain reliever |
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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, DELAYED RELEASE | ||||||||
| RxCUI drug identifier | 308416 | ||||||||
| Application Number | part343 | ||||||||
| Labeler Name | Noble Otc 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 (in each tablet) Aspirin 81 mg (NSAID)
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 •adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours •children under 12 years: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Microcrystalline Cellulose, Silicon dioxide, Talcum, Croscarmellose sodium, Stearic acid, Colloidal silicon dioxide, Titanium dioxide, Triethyl citrate, Methacrylic acid copolymer, D&C Yellow #10, FD&C Yellow #6
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
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.NobleAid PAIN RELIEVER Aspirin ASPIRIN ASPIRIN MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE TALC CROSCARMELLOSE SODIUM STEARIC ACID TITANIUM DIOXIDE TRIETHYL CITRATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER D&C YELLOW NO. 10 FD&C YELLOW NO. 6 I1
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.Packaging image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
• Safe pain relief • Safety enteric-coated aspirin regimen ADULT LOW DOSE Compare to Bayer ® Aspirin active ingredient Questions or comments? Please call (347)378-8990 Monday Through Friday 9-5 or by Email [email protected] This product is not manufactured or distributed by Bayer Healthcare, LLC owner of the Registered Trademark BAYER® Tablets TAMPER EVIDENT Do not use if safety seal under cap is broken or missing. Manufactured for Noble OTC LLC Perth Amboy, NJ 08861 www.nobleotc.com
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 (1-800-222-1222) right away.
Storage and handling
Information about safe storage and handling of the drug product.Other Information: Store at room temperature
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.WARNING Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use 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 non prescription 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. 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, liver 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 •gout •diabetes •arthritis Stop use and ask a doctor if •an allergic reaction occurs. Seek medical help right away. •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 •pain gets worse or lasts more than 10 days •redness or swelling is present •fever lasts more than 3 days •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 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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