FDA Label for Advanced Aspirin
View Indications, Usage & Precautions
Advanced Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Advanced First Aid, 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.
Otc - Active Ingredient
ACTIVE INGREDIENT IN EACH TABLET- ASPIRIN 325 MG
Otc - Purpose
PAIN RELIEVER/FEVER REDUCER
Indications & Usage
Uses:
temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis•
muscle pain • pain and fever of colds • toothache • temporarily reduces fever
Warnings
Uses:
temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis
•
muscle pain • pain and fever of colds • toothache • temporarily reduces fever
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 nonsteroidal anti-inflammatory drugs (NSAIDs),
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 prescription or nonprescription containing an NSAID [aspirin, ibuprofen, naproxen, or
others]
• 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 a sodium-restricted diet
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:
• you feel faint, vomit blood, or have bloody
or black stools
• redness or swelling is present • pain gets worse or lasts more than 10 days • fever lasts
more than 3 days
• new symptoms occur • ringing in the ears or a loss of hearing occurs
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding baby,
ask a health professional
before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN
DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS
SPECIFIC-ALLY 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 right away. Prompt medical attention is critical for
adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions:
•
Drink a full glass of water with each dose
Adults and children 12 years OR OLDER :TAKE 2 TABLETS EVERY 4-6 HOURS AS needed, do not exceed 12 tablets in
24 hours, or as directed by a doctor.
Children under 12 YEARSOF AGE
• consult a doctor
Inactive Ingredient
Inactive Ingredients:
microcrystalline cellulose,
povidone, pregelatinized starch
Package Label.Principal Display Panel
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