FDA Label for Aspirin
View Indications, Usage & Precautions
Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Richmond Pharmaceuticals, Inc.. 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.
Active Ingredient
(in each tablet)
Aspirin 81 mg (NSAID) *
*nonsteroidal anti-inflammatory drug
Purpose
Pain Reliever
Use
- temporarily relieves minor aches and pains
- for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effect may 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 signs of Reye’s syndrome, a rare but serious illness.
Allergy Alert: Aspirin may cause a severe allergic reaction which may include
- hives
- asthma (wheezing)
- shock
- facial swelling
Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child
- has had stomach ulcers or bleeding problems
- take a blood-thinning (anticoagulant) or steroid drug
- takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
- takes more or for a longer time than directed
Do not use
- if the child has ever had an allergic reaction to any other pain reliever / fever reducer
- for at least 7 days after tonsillectomy or oral surgery
Ask a doctor before use if
- stomach bleeding warning applies to your child
- child has a history of stomach problems, such as heartburn
- child has not been drinking fluids
- child has lost a lot of fluid due to vomiting and diarrhea
- child has high blood pressure, heart disease, lever cirrhosis, or kidney disease
- child is taking a diuretic
- child has asthma
Ask a doctor or pharmacist before use if the child is
- taking a prescription drug for diabetes, gout or arthritis
- taking any other drug
- under a doctor’s care for any serious condition
Stop use and ask a doctor if
- child experiences any of the following signs of stomach bleeding:
- feels faint
- vomits blood
- has bloody or black stools
- has stomach pain that does not get better
- pain gets worse or lasts more than 5 days
- any new symptoms appear
- redness or swelling is present in the painful area
- ringing in the ears or a 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 right away.
Directions
DRINK A FULL GLASS OF WATER WITH EACH DOSE
- adults and children 12 years and older : take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours.
- Children under 12 years: ask a doctor
Other Information
- store at 15-30 °C (59-86 °F)
Inactive Ingredients
corn starch, FD&C Yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide, sugar
Questions Or Comments
Call 804-270-4498, 8.30am – 4.30 pm ET Monday-Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Package Label.Principal Display Panel
NDC: 54738-128-36 – 36 COUNT
* Please review the disclaimer below.