FDA Label for Nobleaid Pain Reliever
View Indications, Usage & Precautions
Nobleaid Pain Reliever Product Label
The following document was submitted to the FDA by the labeler of this product Noble Otc Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredient (In Each Tablet)
Aspirin 81 mg (NSAID)
Purpose
Pain Reliever
Uses
For the temporary relief of minor aches and pains
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.
Otc - Keep Out Of Reach Of Children
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.
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.
Other Information:
Store at room temperature
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
Packaging
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