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| Product NDC Code | 50804-421 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Good sense effervescent antacid and pain relief |
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| Type | Brand | ||||||
| Pharm Class | Acidifying Activity [MoA], Alkalinizing Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET, EFFERVESCENT | ||||||
| RxCUI drug identifier | 1536675 | ||||||
| Application Number | part343 | ||||||
| Labeler Name | Good Sense | ||||||
| Packages |
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Overdosage of Good Sense Effervescent Antacid and Pain Relief
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (in each effervescent tablet) Anhydrous Citric acid 1000 mg Aspirin 325 mg (NSAID)* Sodium bicarbonate (heat-treated) 1916 mg *Nonsteroidal anti-inflammatory drug
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients ■ none
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Uses for the temporary relief of ■ heartburn, acid indigestion and sour stomach when accompanied with headache or body aches and pains ■ upset stomach with headache from overindulgence in food or drink ■ headache, body aches and pain alone
Purpose
Information about the drug product’s indications for use.Purpose Anhydrous Citric acid 1000 mg ................................ Antacid Aspirin 325 mg (NSAID)* ..........................................Pain reliever Sodium bicarbonate (heat-treated) 1916 mg ...........Antacid *Nonsteroidal anti-inflammatory drug
Spl product data elements
Usually a list of ingredients in a drug product.Good Sense Effervescent Antacid and Pain Relief Aspirin, Citric Acid, Sodium Bicarbonate ANHYDROUS CITRIC ACID ANHYDROUS CITRIC ACID SODIUM BICARBONATE BICARBONATE ION ASPIRIN ASPIRIN L421
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL GoodSense Pain 36
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ if you have ever had an allergic reaction to this product or any of its ingredients.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ each tablet contains: sodium 524 mg ■ store at room temperature (59º-86ºF)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Serious side effects associated with the use of this product can be reported to the following address: Tower Laboratories LTD. P.O. Box 306 8 Industrial Park Rd. Centerbrook, CT 06409 Distributed by: Perrigo Direct, Inc. Peachtree City, GA 30269 www.PerrigoDirect.com 1-888-228-6937
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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, expect under the advice and supervision of a physician.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant 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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API