FDA Label for Physicians Care 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 - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PHYSICIANS CARE ASPIRIN LABEL
Physicians Care Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Acme United Corporation. 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 (NSAID*) 325 mg
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
Temporarily relieves:
■ headache
■ minor arthritis pain
■ pain & fever of colds
■ backache
■ menstrual cramps
■ toothache
■ muscle aches
Temporarily reduces fever
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
■ shock
■ asthma (wheezing)
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 asthma
■ 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
■ if you are taking prescription drugs for gout, diabetes or arthritis
Otc - When Using
When using this product
- take with food or milk if stomach upset occurs
Otc - Stop Use
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
■ if ringing in the ears or loss of hearing occurs
■ redness or swelling is present in the painful area
■ any new symptoms occur
■ an allergic reaction occurs. Seek medical help right away.
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 older)
Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours unless directed by a doctor.
to exceed 12 tablets in 24 hours
Children under 12 years:
Do not give to children under 12 years of age.
Other Safety Information
Other information
■ use by expiration date on package
■ store at 77°F (25°C); excursions permitted between 59°-86°F (15° - 30°C)
■ avoid excessive heat and humidity
■ tamper evident sealed packets
■ do not use any opened or torn packets
Questions or comments? 1-800-835-2263
Inactive Ingredient
Inactive ingredients
corn starch, hypromellose, polyethylene glycol, propylene glycol
Physicians Care Aspirin Label
90014
Physicians Care®
Aspirin
Pain Reliever and fever Reducer (NSAID)
Pull To Open
This Package for Households without Young Children.
Coated Tablets
Tamper-Evident Oackets of 2 Tablets
Do not use if packet is open or torn.
Aspirin (NSAID) 325 mg
100 Tablets (50 Packets, 2 tablets each)
* Please review the disclaimer below.