FDA Label for Direct Safety Aspirin
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Direct Safety Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Direct Safety. 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.
Other
Drug Facts
Otc - Active Ingredient
Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
temporarily relieves
■ headache
■ muscle pain
■ toothache
■ menstrual pain
■ pain and fever of colds
■ minor pain of arthritis
Warnings
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
If an allergic reaction occurs, stop use and seek medical help right away.
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 nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
■ have 3 or more alcohol drinks every day while using this product
■ take more or for a longer time than directed
Otc - Do Not Use
Do not use if you are allergic to aspirin or to any other pain reliever/fever reducer
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
■ you have asthma
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug for
■ gout
■ diabetes
■ arthritis
Otc - Stop Use
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
■ fever lasts more than 3 days
■ if ringing in the ears or loss of hearing occurs
■ redness or swelling is present
■ new symptoms occur
Otc - Pregnancy Or Breast Feeding
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 right away.
Dosage & Administration
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 Safety Information
Other information
■ store at room temperature
■ avoid excessive heat and humidity
■ tamper evident sealed packets
■ do not use any opened or torn packets
Inactive Ingredient
I nactive ingredients
corn starch, hypromellose*, microcrystalline cellulose*, polyethylene glycol* povidone*, propylene glycol*
* may contain
Otc - Questions
Questions or comments? 1-800-356-9100
Package Label.Principal Display Panel
Direct Safety®
Aspirin
Pain Reliever
Aspirin 325 mg (NSAID)
Aspirina 325 mg (AINE)
This Package is for Households without Young Children.
Este Paquete Es Hogares Sin Ninos Pequenos
Industrial Pack 500
(250 Packets of 2 Tablets)
Direct Safety®
Aspirin
Pain Reliever
Aspirin 325 mg (NSAID)
Aspirina 325 mg (AINE)
This Package is for Households without Young Children.
Este Paquete Es Hogares Sin Ninos Pequenos
Industrial Pack 500
(250 Packets of 2 Tablets)
* Please review the disclaimer below.