FDA Label for Aspirin
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENTS
- DESCRIPTION
Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Genuine First Aid 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.
Active Ingredient (In Each Tablet)
Aspirin (NSAID
*) 325 mg
*nonsteroidal anti-inflammatory drug
Purpose
Pain Reliever / fever reducer
Uses
Temporarily relieves minor aches and pains associated with:
headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of 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, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This 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 thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription 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 have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are:
under a doctor's care for any serious condition; taking any other drug
Otc - When Using
When using this product: take with food or milk if stomach upset occurs
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
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; fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important 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 right away.
Directions
do not use more than directed
the smallest effective dose should be used
drink a full glass of water with each dose
do not take longer than 10 days, unless directed by a doctor
Dosage & Administration
Adults and children: (12 years and older) Take 1 or 2 tablets with
water every 4 hours as needed. Do not take more than 12 tablets in 24
hours, or as directed by a doctor.
Children under 12 years: Do not give to children under 12 years of age.
Storage And Handling
Store at 59 - 86 degree Fahrenheit (15 - 30 degree Celsius); avoid
excessive heat and humidity; tamper evident sealed packets;
Do not use any opened or torn packets
Inactive Ingredients
hypromellose, polyethylene glycol, propylene glycol, corn starch
Description
Distributed by GENUINE FIRST AID
600 Clevelad Str Suite 400, Clearwater, FL 33755
* Please review the disclaimer below.