FDA Label for Aspirin
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- DO NOT USE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- DIRECTIONS
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- KEEP OUT OF REACH OF CHILDREN
- QUESTIONS OR COMMENTS?
- DISTRIBUTED BY:
- LABEL
Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Prostat First Aid. 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
Aspirin 325mg (NSAID)
Nonsteroidal anti-inflammatory drug
Purpose
Pain Reliever / Fever Reducer
Do Not Use
- If you are allergic to aspirin or any other pain releiver / fever reducer
- If you have ever had an allergic reaction to this product or any of its ingredients
Uses
Temporarily relieves:
Headache
Pain and fever of colds
toothache
menstrual pain
muscle pain
minor pain of arthritis
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 behaviour with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a reare but serious illness.
Allergy Alert
Aspirin may cause severe allergic reaction, which may include, facial swelling, hives, shock, asthma (wheezing).
Stomach bleeding warning
This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if you
- Have had stomach ulcers or bleeding problems
- Take blood thinning (anticogulant) or steroid drug
- Are age 60 or older
- take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen or others)
- Take more or for a longer time than directed
- Have 3 or more alcoholic drinks every day while using this product
Ask A Doctor Before Use If
- Stomach bleeding warning applies to you.
- You have a history of stomach problems, such as heartburn
- You have asthma
- You have high blood pressure, heart disease, liver cirrhosis or kidney disease.
- You are taking a diuretic
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug for gout, diabetes, arthritis
Directions
Do not take more than directed. See overdose warning
Drink a full glass of water with each dose
Adults and children 12 years and older
- Take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor.
- Do not use unless directed by a doctor
Children under 12 years
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 stools, have stomach pain that does not get better
- Ringing in the ears or loss of hearing occurs, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days.
- New symptoms occur,
- Redness or swelling is present
- These could be signs of a serious condition
If Pregnant Or Breast-Feeding
Ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Other Information
- Store at 25°C (77°F)
- Excursions permitted between 15°C-30°C (59°F-86°F)
- See end flap for expiration date and lot number
- Use by expiration date on package
- Tamper Evident: Do not use if packet is open or torn
- Read and Keep carton for complete warnings and information
Inactive Ingredients
Corn Starch, Hyperomelose, Polyethylene glycol, propylene glycol
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a poison control center right away.
Questions Or Comments?
Call 1-888-900-2920
Distributed By:
Distributed By:
ProStat First Aid
La Verne, CA. USA
1-888-900-2920
*This product is not manufactured or distributed by the Bayer Healthcare LLC. owner of the registered trademark Bayer®
Made in the USA
* Please review the disclaimer below.