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| Product NDC Code | 68016-678 | ||||
|---|---|---|---|---|---|
| Drug Name | Premier value extra strength freshmint flavor |
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| Type | Brand | ||||
| Pharm Class | Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 476549 | ||||
| Application Number | M001 | ||||
| Labeler Name | CHAIN DRUG CONSORTIUM, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each tablet) Calcium Carbonate USP 675 mg Magnesium hydroxide USP 135 mg
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 ▪ chew 2-4 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablet whole.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch, dextrose, flavor, magnesium stearate, maltodextrin, sucralose. Questions? 1-866-467-2748
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 relieves: ▪ heartburn ▪ sour stomach ▪ acid indigestion
Purpose
Information about the drug product’s indications for use.Purpose Antacid Antacid
Spl product data elements
Usually a list of ingredients in a drug product.Premier Value Extra Strength Freshmint Flavor Calcium Carbonate ,Magnesium Hydroxide CALCIUM CARBONATE CALCIUM CATION MAGNESIUM HYDROXIDE MAGNESIUM CATION STARCH, CORN DEXTROSE, UNSPECIFIED FORM MAGNESIUM STEARATE MALTODEXTRIN SUCRALOSE RP107
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.PRINCIPAL DISPLAY PANEL Premier Value ® NDC# 68016-678-00 COMPARE TO ACTIVE INGREDIENTS IN ROLAIDS® EXTRA STRENGTH* Extra Strength Antacid Tablets Freshmint Flavor Relieves: • Heartburn • Acid Indigestion Antacid/Calcium Supplement 100 CHEWABLE TABLETS GLUTEN FREE TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING *This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Extra Strength Rolaids ® Distributed by: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 Premier Value Extra Strength Antacid tablets
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information ▪ each tablet contains: calcium 270 mg, magnesium 55 mg ▪ store room temperature ▪ Avoid high humidity. DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING CALCIUM SUPPLEMENT USES As a daily source of calcium and magnesium, chew 2 tablets, completely twice daily Supplement Facts Serving Size: 2 Tablets Servings Per Container: 50 Amount Per Serving % Daily Value Calories 8 Total Carbohydrate 2g 1% Total Sugars 2g † Includes 2 g Added Sugar 4% Calcium 540 mg 42% Magnesium 110 mg 26% *Percent Daily Values (DV) are based on a 2,000 calories diet. †Daily Value not established.
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 now taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product ▪ do not take more than 10 tablets in a 24-hour period ▪ do not use the maximum dosage for more than 2 weeks.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-467-2748
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 ▪ do not take more than 10 tablets in a 24-hour period ▪ do not use the maximum dosage for more than 2 weeks.
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 Ask a doctor or pharmacist before use if you are now taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product ▪ do not take more than 10 tablets in a 24-hour period ▪ do not use the maximum dosage for more than 2 weeks. Keep out of reach of children.
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