FDA Label for Publix Fast Relief Effervescent - Original Flavor
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- IN CASE OF OVERDOSE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Publix Fast Relief Effervescent - Original Flavor Product Label
The following document was submitted to the FDA by the labeler of this product Publix Super Markets Inc.. 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 effervescent tablet)
Buffered aspirin 325 mg (NSAID)*
*Nonsteroidal anti-inflammatory drug
Purpose
(in each effervescent tablet)
Buffered aspirin 325 mg (NSAID)*. . . . . . . . . . Pain reliever/fever reducer
*Nonsteroidal anti-inflammatory drug
Uses
■ for the temporary relief of minor aches and pains due to:
■ headache ■ muscle pain ■ backache
■ toothache ■ menstrual pain ■ colds
■ minor arthritis pain
■ temporarily reduces fever
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
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 alcoholic drinks every day while using this product ■ take more or for a longer time than directed
Do Not Use
Do not use ■ if you are allergic to aspirin or any other pain reliever/fever reducer ■ if you have ever had an allergic reaction to this product or any of its ingredients
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 ■ you have a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
Ask a doctor or pharmacist before use if you are taking a prescription drug for
■ diabetes ■ gout ■ arthritis
When Using This Product
When using this product do not exceed recommended dosage
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
■ an allergic reaction occurs. Seek medical help right away.
■ pain lasts for more than 10 days or gets worse
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
■ ringing in the ears or a loss of hearing occurs
If Pregnant Or Breast-Feeding
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.
In Case Of Overdose
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
■ do not exceed recommended dosage
■ to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking
adults and children 12 years and over: 2 tablets every 4 hours, or as directed by a doctor - do not exceed 8 tablets in 24 hours
60 years and over: 2 tablets every 4 hours, or as directed by a doctor - do not exceed 4 tablets in 24 hours
children under 12 years: consult a doctor
Take this product any time – morning, noon or night – when you need relief from headaches, backaches, body aches or muscle pain.
Place two (2) tablets in 4 oz. of water. Dissolve tablets completely.
You do not have to drink any of the residue that may be on the bottom of the glass. The medicines are in the water.
Other Information
■ each tablet contains: sodium 524 mg
■ store at room temperature (59°-86°F). Avoid excessive heat.
Inactive Ingredients
anhydrous citric acid, sodium bicarbonate
* Please review the disclaimer below.