FDA Label for Drug Mart Effervescent Pain Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES FOR THE TEMPORARY RELIEF OF
- 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 BREASTFEEDING,
- OTC - KEEP OUT OF REACH OF CHILDREN
- IN CASE OF OVERDOSE,
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PACKAGE LABEL. PRINCIIPAL DISPLAY PANEL
Drug Mart Effervescent Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Discount Drug Mart, 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 Ingredients
Aspirin 325 mg (NSAID)*
Citric acid 1000 mg
Sodium bicarbonate (heat-treated) 1916 mg
*Nonsteroidal anti-inflammatory drug
Purpose
Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever
Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . . Antacid
Sodium bicarbonate (heat-treated) 1916 mg . . . ..... Antacid
*Nonsteroidal anti-inflammatory drug
Uses For The Temporary Relief Of
■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains
■ upset stomach with headache from overindulgence in food or drink
■ pain alone (headaches or body aches and pains)
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 a nonsteroidal anti-inflammatory drug (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
■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
■ if you are allergic to aspirin ■ if overly full from food or drink. Ask a doctor if severe stomach pain occurs after taking 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ you have a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
■ presently taking a prescription drug. Antacids may interact with certain prescription drugs.
■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis
When Using This Product
do not take more than 8 tablets (adults) or 4 tablets (60 years and over) in a 24-hour period or use the maximum dosage for more than 10 days
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
■ new symptoms occur
■ redness or swelling is present
■ ringing in the ears or a loss of hearing occurs
If Pregnant Or Breastfeeding,
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.
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 (up to 60 years of age): 2 tablets every 4 hours - do not exceed 8 tablets in 24 hours
60 years and over: 2 tablets every 4 hours - 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 heartburn, acid indigestion, sour stomach with headache or body aches and pains.
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)
Inactive Ingredients
■ none
Package Label. Princiipal Display Panel
* Please review the disclaimer below.