Active Ingredient (In Each Tablet)
Aspirin 325mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pharbest Regular Strength Aspirin
FDA Label NDC 16103-365
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharbest Pharmaceuticals, Inc for the product Pharbest Regular Strength Aspirin (NDC 16103-365). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, do not use if, ask a doctor before use if, ask a doctor or pharmacist before use if you are taking a prescription drug for:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/ fever reducer
Uses
temporarily relieves
- headache
- muscle pain
- toothache
- menstrual pain
- pain and fever of colds
- minor pains 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 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
- asthma (wheezing)
- facial swelling
- shock
- 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 alcoholic drinks every day while using this product
- take more or for a longer time than directed
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
Do Not Use If
you are allergic to aspirin or any other pain reliever/fever reducer
Ask A Doctor Before Use If
- the 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 have asthma
- you are taking a diuretic
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:
- 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
- allergic reaction occurs
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- any new symptoms occur
- ringing in the ears or loss of hearing occurs
- fever lasts more than 3 days
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 accidental 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 over | take 1 to 2 tablets every 4 hours. Do not exceed 12 tablets in 24 hours |
| children 6 to under 12 years | consult a physician |
Other Information
- store at 20°-25°C (68°-77°F)
- avoid excess heat and moisture
Inactive Ingredients
Corn starch
Questions?
Adverse drug event call: (866) 562-2756 (Mon- Fri 8 AM-5PM EST)
Package Label.Principal Display Panel
Manufactured in the U.S.A
Pharbest
Regular Strength
*Compare to active ingredient in Genuine Bayer® Aspirin
Aspirin
Pain Reliever • Fever Reducer (NSAID)
Aspirin, 325 mg each
* Please review the disclaimer below.
