FDA Label for Cvs Health Extra Strength Antacid And Pain Reliever
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- 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 OF BREAST-FEEDING
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Cvs Health Extra Strength Antacid And Pain Reliever Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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
(in each effervescent tablet)
Anhydrous citric acid 1000mg
Aspirin 500 mg (NSAID)*
Sodium bicarbonate (heat-treated) 1985 mg
*Nonsteroidal anti-inflammatory drug
Purpose
Anhydrous citric acid 1000mg……………………………………….Antacid
Aspirin 500 mg (NSAID)*…………………………………………...Pain Reliever
Sodium bicarbonate (heat-treated) 1985 mg………………………….Antacid
*Nonsteroidal anti-inflammatory drug
Uses
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
■ headache, body aches, and pain alone
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 non-prescription 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 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
■ 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
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 2 weeks, except under the advice and supervision of a physician.
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
■ new symptoms occur
■ redness or swelling is present
■ ringing in the ears or a loss of hearing occurs
If Pregnant Of 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.
Overdosage
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
Other Information
■ each tablet contains: sodium 575 mg
■ store at room temperature (59°-86°F)
Inactive Ingredients
flavor
Questions Or Comments?
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